Clinical trials: Advanced Fibrosis
Nonalcoholic Steatohepatitis
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of…
- Trial name
- NASH-FX (NCT02421094)
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatic Impairment
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
- Trial name
- NCT04469920
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 2 sites in United States
- Volunteers
- 98 people
- Sponsor
- Zydus Therapeutics Inc.
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
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis
To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)
- Trial name
- NCT07848191
- Testing
- Rezdiffra, Resmetirom, ACTOS/pioglitazone
- Where
- 16 sites in United States
- Volunteers
- 150 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
HCC, Liver Cirrhosis
Open Label Trial of Immunotherapy for Advanced Liver Cancer
The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.
- Trial name
- HCC (NCT02256514)
- Testing
- Daily oral dose of hepcortespenlisimut-L
- Where
- Mongolia
- Volunteers
- 120 people
- Sponsor
- Immunitor LLC
Cirrhosis, Ascites
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
- Trial name
- NCT00968695
- Testing
- Albumin
- Where
- 6 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis C
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced…
- Trial name
- NCT02319031
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 10 sites in Australia, France
- Volunteers
- 53 people
- Sponsor
- Bristol-Myers Squibb
Healthy, Metabolic Dysfunction-associated Steatohepatitis
A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People and Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following…
- Trial name
- NCT06575400
- Testing
- BI 3804379
- Where
- Belgium
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis, Advanced Lung Disease
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
- Trial name
- NCT02390219
- Testing
- Lumacaftor, Ivacaftor
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Liver Fibrosis, Hepatic Cirrhosis
The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.
- Trial name
- PECHORA (NCT07069725)
- Testing
- AZD2389, PET scan and radioligand
- Where
- Sweden
- Volunteers
- 8 people
- Sponsor
- AstraZeneca
Hepatitis B, Chronic
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
- Trial name
- NCT02224456
- Testing
- Tenofovir disoproxil fumarate
- Where
- 19 sites in China
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Idiopathic Pulmonary Fibrosis
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced…
- Trial name
- NCT02951429
- Testing
- Pirfenidone, Sildenafil
- Where
- 56 sites in Belgium, Canada and 11 more
- Volunteers
- 177 people
- Sponsor
- Hoffmann-La Roche
Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects…
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver, NAFLD
- Trial name
- ASCEND (NCT05402371)
- Testing
- Rencofilstat
- Where
- 41 sites in United States, France and 1 more
- Volunteers
- 120 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
- Trial name
- NCT01899859
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Galectin Therapeutics Inc.
Acquired Bleeding Disorder, Cirrhosis
Use of NovoSeven® in Active Variceal Bleeding
This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.
- Trial name
- NCT00154492
- Testing
- activated recombinant human factor VII
- Where
- 44 sites in Austria, Czechia and 10 more
- Volunteers
- 265 people
- Sponsor
- Novo Nordisk A/S
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
This study is open to adults who are at least 18 years old living with obesity and have: a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and moderate or advanced…
- Trial name
- NCT06632444
- Testing
- Survodutide
- Where
- 532 sites in United States, Argentina and 35 more
- Volunteers
- 1,800 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
- Trial name
- NCT02802345
- Testing
- Nintedanib, Sildenafil
- Where
- 85 sites in United States, Australia and 11 more
- Volunteers
- 274 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease
This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40% predicted) will be enrolled.
- Trial name
- NCT00311506
- Volunteers
- 25 people
- Sponsor
- Genentech, Inc.
Skin Graft Complications
Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery.
- Trial name
- NCT06134843
- Testing
- DERMASEAL
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Hobart W. Harris