Non-alcoholic SteatohepatitisNCT02231333
The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis
A study testing S-adenosylmethionine (SAMe) and pentoxiphylline (PTX) in people with Non-alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- S-adenosylmethionine (SAMe) and pentoxiphylline (PTX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2013to 31 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Persistently abnormal ALT >1.2 times upper limit of normal
- Histological evidence of NASH (Non alcoholic Steatohepatitis) on liver biopsy. The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and fibrosis up to stage 3 as per Burnt stating.
Who cannot join
- Alcohol intake of more than 40gm / week with features suggestive chronic liver disease .
- Other known cause of chronic liver disease like Hepatitis B,C, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, PSC (Primary Sclerosis Cholangitis).
- Patient on Medication like estrogens, amiodarone, MTx, tamoxifen, ATT (Antitubercular Treatment)
- Pregnancy or lactation
- Hypersensitivity to methylxanthines (e.g., caffeine, theophylline,)
- Recent retinal/cerebral hemorrhage
- Acute myocardial infarction or severe cardiac arrhythmias.
- Impaired renal function.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Randomized Controlled Trial to Study the Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis.
Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. It is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis. NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment available till date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. Role of SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. However the usefulness of SAMe in NAFLD is not known till now. Hence this study has been designed.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- S-adenosylmethionine (SAMe), pentoxiphylline (PTX)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-adenosylmethionine (SAMe)Drug
pentoxiphylline (PTX)Drug
| Study group | Role | What they receive |
|---|---|---|
| S-adenosylmethionine (SAMe) | Experimental | Not described Receives: Drug: S-adenosylmethionine (SAMe) |
| pentoxiphylline (PTX) | Active comparator | Not described Receives: Drug: pentoxiphylline (PTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical improvement in the form of AST/ALT
Measured: 1 Years
Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter)
Measured: 1 years
Secondary outcomes (5)
Metabolic response in form of anthropometry.
metabolic response in form of anthropometry (BMI, waist circumference).
Measured: 1 Years
Fasting lipid profiles
Measured: 1 Years
Reduction in uric acid levels
Measured: 1 Years
Reduction in pro- inflammatory cytokines
Measured: 1 Years
Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start1 Jul 2013
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Devaraja R, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231333
- Sponsor's protocol ID
- ILBS-NASH-01
- Status last verified
- Oct 2019
- First submitted
- 30 Aug 2014
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Study the Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis.
- ClinicalTrials.gov ID
- NCT02231333
- Acronym / sponsor ID
- ILBS-NASH-01
- Conditions
- Non-alcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. It is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis. NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment available till date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. Role of SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. However the usefulness of SAMe in NAFLD is not known till now. Hence this study has been designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-adenosylmethionine (SAMe) | Experimental | Drug: S-adenosylmethionine (SAMe) |
| pentoxiphylline (PTX) | Active comparator | Drug: pentoxiphylline (PTX) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 70 years
- Persistently abnormal ALT >1.2 times upper limit of normal
- Histological evidence of NASH (Non alcoholic Steatohepatitis) on liver biopsy. The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and fibrosis up to stage 3 as per Burnt stating.
Key exclusion criteria (8 listed)
- Alcohol intake of more than 40gm / week with features suggestive chronic liver disease .
- Other known cause of chronic liver disease like Hepatitis B,C, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, PSC (Primary Sclerosis Cholangitis).
- Patient on Medication like estrogens, amiodarone, MTx, tamoxifen, ATT (Antitubercular Treatment)
- Pregnancy or lactation
- Hypersensitivity to methylxanthines (e.g., caffeine, theophylline,)
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 |
|---|---|---|
| S-adenosylmethionine (SAMe) | Drug | S-adenosylmethionine (SAMe) |
| pentoxiphylline (PTX) | Drug | pentoxiphylline (PTX) |
Primary outcome
Biochemical improvement in the form of AST/ALT
Time frame: 1 Years
Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter)
Time frame: 1 years
5 secondary outcomes
Metabolic response in form of anthropometry.
Time frame: 1 Years
Fasting lipid profiles
Time frame: 1 Years
Reduction in uric acid levels
Time frame: 1 Years
Reduction in pro- inflammatory cytokines
Time frame: 1 Years
Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis.
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
Related trials for Non-alcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
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
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.
Dr Devaraja R, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-adenosylmethionine (SAMe) and pentoxiphylline (PTX) in people with Non-alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 3 inclusion and 8 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 29 Oct 2019. 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 India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biochemical improvement in the form of AST/ALT (time frame: 1 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2019.