Non-alcoholic SteatohepatitisPhase 2NCT03656068

An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis

A Phase 2 study testing Nitazoxanide 500mg BID in people with Non-alcoholic Steatohepatitis and Fatty Liver, run by Pinnacle Clinical Research, PLLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver
What is being tested?: Nitazoxanide 500mg BID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2018to 25 Nov 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged from 18 to 75 years inclusive the Screening Visit.
Must provide signed written informed consent and agree to comply with the study protocol.
Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study
Histological confirmation of steatohepatitis on a diagnostic liver biopsy (biopsy obtained within 6 months prior to Screening or during the Screening Period) with at least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
Fibrosis stage of 2 or 3, according to the NASH Clinical Research Network fibrosis staging system on a diagnostic liver biopsy (biopsy obtained within 6 months prior to Screening or during the Screening Period).
Two assessments of ALT, AST, Total bilirubin, Alkaline phosphatase (ALP), Creatine phosphokinase (CPK) will be collected during screening at least 4 weeks apart. To be eligible the second value cannot be ≥2x the first value.

Who cannot join

History of efficient bariatric surgery within 5 years prior to Screening, or planned bariatric surgery in the course of the study.
Patients with HbA1c >10.0%. If abnormal at the first Screening Visit, the HbA1c measurement can be repeated. A repeated abnormal HbA1c (HbA1c >10.0%) leads to exclusion.
Patients with a history of clinically significant acute cardiac event within 6 months prior to Screening such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
Weight loss of more than 10% within 6 months prior to Randomization.
Patient with any history or presence of decompensated cirrhosis.
Current or recent history (<1 year) of significant alcohol consumption. For men, significant consumption is typically defined as higher than 30 g pure alcohol per day. For women, it is typically defined as higher than 20 g pure alcohol per day.

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Current or history of other substance abuse within 1 year prior to screening.
Pregnant or lactating females or females planning to become pregnant during the study period.
Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
Positive hepatitis B surface antigen (HBsAg)
Positive Hepatitis C virus (HCV) RNA, (tested for in case of known cured HCV infection, or positive HCV Ab at Screening)
Suspicion of drug-induced liver disease
Alcoholic liver disease
Autoimmune hepatitis
Wilson's disease
Primary biliary cirrhosis, primary sclerosing cholangitis
Genetic homozygous hemochromatosis
Known or suspected Hepatocellular Carcinoma
History or planned liver transplant, or current Model for End-Stage Liver Disease score >15.
Patients who cannot be contacted in case of emergency.
Known hypersensitivity to the investigation product or any of its formulation excipients.
Patients who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices.
Patients who are currently participating in, plan to participate in, or have participated in an investigational drug trial or medical device trial containing active substance within 30 days or five half-lives, whichever is longer, prior to Screening.
Evidence of any other unstable or, untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic, or psychiatric disease.
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
History of noncompliance with medical regimens, or patients who are considered to be unreliable.
Positive anti-human immunodeficiency virus (HIV) antibody.
AST and/or ALT >10 x upper limit of normal (ULN).
Total bilirubin >1.3 mg/dL due to altered hepatic function.
Direct bilirubin > ULN Note: Gilbert Disease patients are allowed into the study.
International Normalized Ratio >1.2 in the absence of anticoagulant therapy.
Platelet count <150,000/mm3 in the context of portal hypertension.
Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate of less than 60 ml/min/1.73 m2).

Trial locations and contacts

1 site in 1 country.

United States1 site

Pinnacle Clinical Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Monocentric, Open-Label, Proof of Concept Study to Evaluate the Safety and Efficacy of Nitazoxanide at 500mg Twice Daily on Collagen Turnover in Plasma in NASH Patients With Fibrosis Stage 2 or 3

To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis

Read the detailed description

Based on the anti-fibrotic properties demonstrated in the animal models of fibrosis, this proof of concept clinical study aims at evaluating NTZ in patients with non-alcoholic steatohepatitis (NASH) and fibrosis stage 2 and 3. Although NTZ has been evaluated in liver disease populations up to 60 weeks, this is the first study evaluating NTZ treatment in a population with NASH induced stage 2 and 3 fibrosis. The aim of this study is to evaluate the safety and tolerability of NTZ 500 mg BID after 24 weeks of treatment in this population.

This proof of concept study will also evaluate the anti-fibrotic effect of NTZ as a secondary objective.

The methods of evaluation of fibrosis will include an innovative method of metabolic labeling.This approach is based on the concept that liver status can be determined by measuring the ratio of newly synthesized/pre-existing proteins.The turn-over rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients will be given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results are expressed as fractional synthesis rate of these proteins (FSR). This method has been previously published (Decaris et al, 2017).

Other non-invasive methods will be used to evaluate the liver stiffness changes after NTZ treatment: Magnetic Resonance Elastography (MRE) and FibroScan®.

Conditions: Non-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis
Being tested: Nitazoxanide 500mg BID
Medical subject headings: Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nitazoxanide 500mg BIDDrug
Also called NTZ
Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks

Study groups in NCT03656068
Study group	Role	What they receive
Open label NTZ	Experimental	Open label. All patients will receive study drug Receives: Drug: Nitazoxanide 500mg BID

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE)
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of treatment-emergent adverse events (TEAEs).
Measured: 28 weeks
Number of NTZ Treated Participants Presenting Any Study Drug Related TEAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related treatment-emergent adverse events (TEAEs).
Measured: 28 weeks
Number of NTZ Treated Participants Presenting Any SAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of serious adverse events (SAEs).
Measured: 28 weeks
Number of NTZ Treated Participants Presenting Study Drug-Related SAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related serious adverse events (SAEs).
Measured: 28 weeks
Deaths Due to AE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of deaths due to adverse events (AEs).
Measured: 28 weeks
Number of NTZ Treated Participants Presenting Any AE Leading to Withdrawal From Study or Study Drug
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of adverse events (AEs) leading to withdrawal from study or study drug.
Measured: 28 weeks
Number of NTZ Treated Participants Presenting Any Study Drug-related AE Leading to Withdrawal From Study or Study Drug
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related adverse events (AEs) leading to withdrawal from study or study drug
Measured: 28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Clinical Laboratory Evaluations
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing clinical laboratory evaluations. Changes in clinical laboratory evaluations were considered clinically significant or not as per Investigator judgment.
Measured: 28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Vital Signs
To assess the safety and tolerability of NTZ after 24 weeks of treatment by measuring vital signs. Changes in vital signs were considered clinically significant or not as per Investigator judgement
Measured: 28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Electrocardiogram Parameters
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing electrocardiograms (ECGs). Changes in ECGs parameters were considered clinically significant or not as per Investigator judgement.
Measured: 28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Physical Examinations
To assess the safety and tolerability of NTZ after 24 weeks of treatment by conducting physical examinations. Changes in physical examinations were considered clinically significant or not as per Investigator judgement.
Measured: 28 weeks

Secondary outcomes (72)

Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
Change in Lumican Fractional Synthesis Rate (FSR) from baseline to end of treatment evaluated through the use of deuterated water.
Lumican is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR). This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity.
Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein.
Measured: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
Percent Change in Lumican FSR from baseline to end of treatment evaluated through the use of deuterated water.
Lumican is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR). This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity.
Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein.
Measured: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
Change in transforming growth factor beta-induced-protein (TGFBI) Fractional Synthesis Rate (FSR) from baseline to end of treatment evaluated through the use of deuterated water.
TGFBI is a marker indicative of hepatic fibrogenesis with its turnover assessed by FSR.
This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity.
Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results were expressed as FSR of these proteins.
Measured: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
Percent Change in transforming growth factor beta-induced protein (TGFBI) FSR from baseline to end of treatment evaluated through the use of deuterated water.
TGFBI is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR).
This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity.
Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results were expressed as FSR of these proteins.
Measured: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan®
FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit.
The CAP score is a measurement of fatty change in the liver, naming the steatosis grade. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m. 100 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis (steatosis S1), 260 to 290 dB/m indicates moderate steatosis (steatosis S2), and a CAP score greater than 290 dB/m indicates severe steatosis (steatosis S3).
Measured: 24 weeks
Percent Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan®
FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit.
The CAP score is a measurement of fatty change in the liver, naming the steatosis grade.The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m. 100 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis (steatosis S1), 260 to 290 dB/m indicates moderate steatosis (steatosis S2), and a CAP score greater than 290 dB/m indicates severe steatosis (steatosis S3).
Measured: 24 weeks
Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan®
FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit.
The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa indicating the abscence of abscence of fibrosis (F0) or a potential fibrosis of stage 1 (F1). The highest possible result is 75 kPa indicating advanced liver fibrosis of stage 4 (F4).
Measured: 24 weeks
Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan®
FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit.
The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa indicating the abscence of abscence of fibrosis (F0) or a potential fibrosis of stage 1 (F1). The highest possible result is 75 kPa indicating advanced liver fibrosis of stage 4 (F4).
Measured: 24 weeks
Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit.
Measured: 12 weeks
Percent Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit.
Measured: 12 weeks
Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit.
Measured: 24 weeks
Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit.
Measured: 24 weeks
Change in Alpha-2 Macroglobulin From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Alpha-2 Macroglobulin From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Alpha-2 Macroglobulin From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Alpha-2 Macroglobulin From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Fibroblast Growth Factor 19 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Fibroblast Growth Factor 19 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Fibroblast Growth Factor 21 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Fibroblast Growth Factor 21 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Human Chitinase 3-like 1 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Human Chitinase 3-like 1 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Human Chitinase 3-like 1 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Human Chitinase 3-like 1 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Hyaluronic Acid From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Hyaluronic Acid From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Hyaluronic Acid From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Hyaluronic Acid From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk
Measured: 12 weeks
Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk.
Measured: 12 weeks
Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk.
Measured: 24 weeks
Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk.
Measured: 24 weeks
Change in M30 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in M30 Biomarker From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in M30 Biomarker From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in M30 Biomarker From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in M65 Biomarker From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in M65 Biomarker From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in M65 Biomarker From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in M65 Biomarker From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in miR34a Fold From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in miR34a Fold From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in miR34a Fold From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in miR34a Fold From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Pro-C3 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Pro-C3 From Baseline to Week 12
The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1).
Measured: 12 weeks
Change in Pro-C3 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Pro-C3 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Pro-C6 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Pro-C6 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Pro-C6 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Pro-C6 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Procollagen 3 N-terminal Pro-peptide From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Procollagen 3 N-terminal Pro-peptide From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Procollagen 3 N-terminal Pro-peptide From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Procollagen 3 N-terminal Pro-peptide From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Percent Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to Week 12
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 12 weeks
Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Percent Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to End of Treatment
Non-invasive Fibrosis Biomarkers were assessed in blood samples.
Measured: 24 weeks
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to Week 12
NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis.
Measured: 12 weeks
Percent Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to Week 12
NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis.
Measured: 12 weeks
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to End of Treatment
NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis.
Measured: 24 weeks
Percent Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to End of Treatment
NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis.
Measured: 24 weeks
Change in Fibrosis-4 Score From Baseline to Week 12
Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6.
Measured: 12 weeks
Percent Change in Fibrosis-4 Score From Baseline to Week 12
Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6.
Measured: 12 weeks
Change in Fibrosis-4 Score From Baseline to End of Treatment
Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6.
Measured: 24 weeks
Percent Change in Fibrosis-4 Score From Baseline to End of Treatment
Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201825 Nov 2020

First posted4 Sep 2018
Study start4 Dec 2018
Primary completion25 Nov 2020
Study completion25 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03656068
Sponsor's protocol ID: NTZ-218-1
Status last verified: Jun 2022
First submitted: 29 Aug 2018
Last updated: 30 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease

All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Monocentric, Open-Label, Proof of Concept Study to Evaluate the Safety and Efficacy of Nitazoxanide at 500mg Twice Daily on Collagen Turnover in Plasma in NASH Patients With Fibrosis Stage 2 or 3
ClinicalTrials.gov ID: NCT03656068
Acronym / sponsor ID: NTZ-218-1
Conditions: Non-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Pinnacle Clinical Research, PLLCUniversity, hospital or other
Study start: 4 Dec 2018 (actual)
Primary completion: 25 Nov 2020 (actual)
Study completion: 25 Nov 2020 (actual)
First posted: 4 Sep 2018 (actual)
Results: Posted 30 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis

Detailed description

This proof of concept study will also evaluate the anti-fibrotic effect of NTZ as a secondary objective.

Other non-invasive methods will be used to evaluate the liver stiffness changes after NTZ treatment: Magnetic Resonance Elastography (MRE) and FibroScan®.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label NTZ	Experimental	Drug: Nitazoxanide 500mg BIDOpen label. All patients will receive study drug

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males or females aged from 18 to 75 years inclusive the Screening Visit.
Must provide signed written informed consent and agree to comply with the study protocol.
Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study
Histological confirmation of steatohepatitis on a diagnostic liver biopsy (biopsy obtained within 6 months prior to Screening or during the Screening Period) with at least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
Fibrosis stage of 2 or 3, according to the NASH Clinical Research Network fibrosis staging system on a diagnostic liver biopsy (biopsy obtained within 6 months prior to Screening or during the Screening Period).

Key exclusion criteria (33 listed)

History of efficient bariatric surgery within 5 years prior to Screening, or planned bariatric surgery in the course of the study.
Patients with HbA1c >10.0%. If abnormal at the first Screening Visit, the HbA1c measurement can be repeated. A repeated abnormal HbA1c (HbA1c >10.0%) leads to exclusion.
Patients with a history of clinically significant acute cardiac event within 6 months prior to Screening such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
Weight loss of more than 10% within 6 months prior to Randomization.
Patient with any history or presence of decompensated cirrhosis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nitazoxanide 500mg BIDAlso: NTZPatients will receive 500mg of Nitazoxanide BID daily for 24 weeks	Drug	Open label NTZ

Primary outcome

Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE)
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of treatment-emergent adverse events (TEAEs).
Number of NTZ Treated Participants Presenting Any Study Drug Related TEAE
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related treatment-emergent adverse events (TEAEs).
Number of NTZ Treated Participants Presenting Any SAE
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of serious adverse events (SAEs).
Number of NTZ Treated Participants Presenting Study Drug-Related SAE
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related serious adverse events (SAEs).
Deaths Due to AE
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of deaths due to adverse events (AEs).
Number of NTZ Treated Participants Presenting Any AE Leading to Withdrawal From Study or Study Drug
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of adverse events (AEs) leading to withdrawal from study or study drug.
Number of NTZ Treated Participants Presenting Any Study Drug-related AE Leading to Withdrawal From Study or Study Drug
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related adverse events (AEs) leading to withdrawal from study or study drug
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Clinical Laboratory Evaluations
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing clinical laboratory evaluations. Changes in clinical laboratory evaluations were considered clinically significant or not as per Investigator judgment.
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Vital Signs
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by measuring vital signs. Changes in vital signs were considered clinically significant or not as per Investigator judgement
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Electrocardiogram Parameters
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing electrocardiograms (ECGs). Changes in ECGs parameters were considered clinically significant or not as per Investigator judgement.
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Physical Examinations
Time frame: 28 weeks
To assess the safety and tolerability of NTZ after 24 weeks of treatment by conducting physical examinations. Changes in physical examinations were considered clinically significant or not as per Investigator judgement.

72 secondary outcomes

Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
Time frame: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
Time frame: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
Time frame: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
Time frame: From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan®
Time frame: 24 weeks
Percent Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan®
Time frame: 24 weeks
Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan®
Time frame: 24 weeks
Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan®
Time frame: 24 weeks
Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Time frame: 12 weeks
Percent Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Time frame: 12 weeks
Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Time frame: 24 weeks
Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE)
Time frame: 24 weeks
Change in Alpha-2 Macroglobulin From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Alpha-2 Macroglobulin From Baseline to Week 12
Time frame: 12 weeks
Change in Alpha-2 Macroglobulin From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Alpha-2 Macroglobulin From Baseline to End of Treatment
Time frame: 24 weeks
Change in Fibroblast Growth Factor 19 From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Fibroblast Growth Factor 19 From Baseline to Week 12
Time frame: 12 weeks
Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment
Time frame: 24 weeks
Change in Fibroblast Growth Factor 21 From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Fibroblast Growth Factor 21 From Baseline to Week 12
Time frame: 12 weeks
Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment
Time frame: 24 weeks
Change in Human Chitinase 3-like 1 From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Human Chitinase 3-like 1 From Baseline to Week 12
Time frame: 12 weeks
Change in Human Chitinase 3-like 1 From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Human Chitinase 3-like 1 From Baseline to End of Treatment
Time frame: 24 weeks
Change in Hyaluronic Acid From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Hyaluronic Acid From Baseline to Week 12
Time frame: 12 weeks
Change in Hyaluronic Acid From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Hyaluronic Acid From Baseline to End of Treatment
Time frame: 24 weeks
Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12
Time frame: 12 weeks
Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12
Time frame: 12 weeks
Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment
Time frame: 24 weeks
Change in M30 From Baseline to Week 12
Time frame: 12 weeks
Percent Change in M30 Biomarker From Baseline to Week 12
Time frame: 12 weeks
Change in M30 Biomarker From Baseline to End of Treatment
Time frame: 24 weeks
Percent Change in M30 Biomarker From Baseline to End of Treatment
Time frame: 24 weeks

Results and safety

Results posted to the registry on 30 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NTZ 500 mg BID	21	16

Primary outcome: Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE)

Time frame: 28 weeks. Count of participants. Unit: Participants

Measure	NTZ 500 mg BID n = 21
No of participants with at least one TEAE	20
TEAE maximum severity: Grade 1 (mild)	7
TEAE maximum severity: Grade 2 (moderate)	10
TEAE maximum severity: Grade 3 (severe)	3
TEAE maximum severity: Grade 4 (life-threatening)	0
TEAE maximum severity: Grade 5 (death)	0
No of participants with no TEAE	1

Population analysed: The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug.

Primary outcome: Number of NTZ Treated Participants Presenting Any Study Drug Related TEAE

Time frame: 28 weeks. Count of participants. Unit: Participants

Measure	NTZ 500 mg BID n = 21
No of participants with at least 1 treatment-related TEAE	18
TEAE maximum severity: Grade 1 (mild)	10
TEAE maximum severity: Grade 2 (moderate)	8
TEAE maximum severity: Grade 3 (severe)	0
TEAE maximum severity: Grade 4 (life-threatening)	0
TEAE maximum severity: Grade 5 (death)	0
No of participants with no study drug-related TEAE	3

Population analysed: The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug.

Primary outcome: Number of NTZ Treated Participants Presenting Any SAE

Time frame: 28 weeks. Count of participants. Unit: Participants

Measure	NTZ 500 mg BID n = 21
At least one SAE	4
No SAE	17

Population analysed: The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug.

Primary outcome: Number of NTZ Treated Participants Presenting Study Drug-Related SAE

Time frame: 28 weeks. Count of participants. Unit: Participants

Measure	NTZ 500 mg BID n = 21
At least one study-drug related SAE	0
No study-drug related SAE	21

Population analysed: The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug.

72 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the signature of the informed consent form (ICF) until the end of study, week 28, i.e. 4 weeks after the last administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NTZ 500 mg BID	4 of 21 (19%)	20 of 21 (95.2%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen Harrison, MD principal investigator

Pinnacle Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nitazoxanide 500mg BID in people with Non-alcoholic Steatohepatitis and Fatty Liver, run by Pinnacle Clinical Research, PLLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE) (time frame: 28 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.