Clinical trials: Hepatic Fibrosis
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Hepatitis B
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic…
- Trial name
- NCT04971928
- Testing
- GSK3228836
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an…
- Trial name
- NCT03420768
- Testing
- BMS-986263
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
MASH, MASLD
Global Research Initiative for Patients Screening on MASH
GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe…
- Conditions
- MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver
- Trial name
- GRIPonMASH (NCT05651724)
- Where
- 13 sites in Belgium, Czechia and 8 more
- Volunteers
- 10,000 people
- Sponsor
- Julius Clinical
Hepatitis C, Chronic
An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.
- Trial name
- NCT01671046
- Where
- 10 sites in Brazil
- Volunteers
- 123 people
- Sponsor
- Hoffmann-La Roche
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hepatitis C Virus
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or…
- Trial name
- ACCORDION-1 (NCT02349048)
- Testing
- Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
- Where
- 8 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatic Insufficiency
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT00968591
- Testing
- Everolimus
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Liver Fibrosis, Liver Steatosis
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis.
- Trial name
- NCT03957070
- Testing
- Liver Incyte
- Where
- 2 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sonic Incytes
Liver Fibrosis
Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls
This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal…
- Trial name
- NCT07394309
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatic Impairment, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
Liver Fat, Liver Fibrosis
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease…
- Conditions
- Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes
- Trial name
- Ertu-NASH (NCT05644717)
- Testing
- Ertugliflozin 5 mg, 15mg
- Where
- Pakistan
- Volunteers
- 164 people
- Sponsor
- Getz Pharma
Nonalcoholic Steatohepatitis
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
- Trial name
- AURORA (NCT03028740)
- Testing
- Cenicriviroc
- Where
- 346 sites in United States, Australia and 26 more
- Volunteers
- 1,778 people
- Sponsor
- Tobira Therapeutics, Inc.
Liver Fibrosis, Fatty Liver
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis…
- Trial name
- NCT06051669
- Testing
- iLivTouch, FibroScan
- Where
- 4 sites in United States
- Volunteers
- 418 people
- Sponsor
- New Discovery LLC
Hepatic Impairment
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh…
- Trial name
- NCT05009680
- Testing
- GB1211
- Where
- 4 sites in Bulgaria
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
Hepatic Impairment
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT02581592
- Testing
- TD-4208
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.