Clinical trials: Compensated Cirrhosis
HIV Infections, Hepatitis C
Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy
The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in HIV/HCV coinfected…
- Trial name
- NCT00437684
- Testing
- LPV/r, PEG-IFNa 2a, Ribavirin
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
Hepatitis C, Cirrhosis
Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral…
- Trial name
- NCT05467826
- Testing
- Sofosbuvir/Velpatasvir + Ribavirin, Sofosbuvir/Velpatasvir/Voxilaprevir
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
- Trial name
- STELLAR-4 (NCT03053063)
- Testing
- SEL
- Where
- 283 sites in United States, Australia and 20 more
- Volunteers
- 883 people
- Sponsor
- Gilead Sciences
Alcoholic Liver Disease
Cognitive Function of Alcoholic Compensated Liver Cirrhosis
Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis
- Trial name
- NCT04557774
- Testing
- Cognitive function test
- Where
- South Korea
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Chuncheon Sacred Heart Hospital
Alcoholic or Viral C Compensated Cirrhosis
Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis?
The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations.
- Trial name
- ABOCIRRALVIR (NCT03342170)
- Testing
- G20210A prothrombin gene mutation and Factor 5 Leiden mutation
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- University Hospital, Caen
NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks.
- Trial name
- NCT04383951
- Testing
- Dietary consult for participants in the ketogenic diet arm, Dietary consult for participants in the standard of care arm
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Indiana University
Compensated Cirrhosis, Gastroesophageal Varices Bleeding
Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis
Gastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal haemorrhage is recommended if high-risk varices (HRV) are detected.
- Trial name
- NCT03749954
- Testing
- Detachable string magnetically controlled capsule endoscopy
- Where
- 13 sites in China, United Kingdom
- Volunteers
- 105 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated…
- Trial name
- NCT06920043
- Testing
- Efimosfermin
- Where
- 30 sites in United States
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02243280
- Testing
- ABT-493, ABT-530
- Volunteers
- 174 people
- Sponsor
- AbbVie
Compensated Cirrhosis, Obesity
Effects of Weight Loss on Portal Pressure in Patients With Overweight/Obesity and Cirrhosis
Overweight/obesity is increasing both in the general population and in patients with cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for clinical decompensation independent of liver function and…
- Trial name
- SPORTDIET (NCT01409356)
- Testing
- Diet + exercise
- Where
- 6 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Hospital Clinic of Barcelona
Early Cirrhosis
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in…
- Trial name
- NCT03855956
- Testing
- KB174, Maltodextrin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Kaleido Biosciences
Portal Hypertension
A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis.
- Trial name
- NCT05251272
- Testing
- Hepatic venous pressure gradient
- Where
- 5 sites in China
- Volunteers
- 300 people
- Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
Hepatitis C Virus (HCV)
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate…
- Trial name
- EXPEDITION-8 (NCT03089944)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 113 sites in United States, Bulgaria and 17 more
- Volunteers
- 343 people
- Sponsor
- AbbVie
Liver Cirrhosis
Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B).
- Trial name
- NCT04874428
- Testing
- Rivaroxaban 10 mg Oral Tablet, Apixaban 2.5 mg Oral Tablet
- Where
- Switzerland
- Volunteers
- 24 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Nonalcoholic Steatohepatitis (NASH)
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
- Trial name
- NCT04267393
- Testing
- BMS-986263
- Where
- 112 sites in United States, Argentina and 14 more
- Volunteers
- 124 people
- Sponsor
- Bristol-Myers Squibb
Compensated Liver Cirrhosis, Gastroesophageal Varices Bleeding
Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension.
- Trial name
- NCT03778775
- Testing
- Liver sitffness measurement
- Where
- 16 sites in China, Indonesia and 3 more
- Volunteers
- 200 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Hypertension, Portal
A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this…
- Trial name
- NCT05161481
- Testing
- Avenciguat (BI 685509)
- Where
- 45 sites in United States, Argentina and 20 more
- Volunteers
- 80 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis C Virus (HCV)
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or…
- Trial name
- NCT02517528
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 104 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients
The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000 /μL, suggestive of compensated cirrhosis) to…
- Trial name
- NCT01636778
- Testing
- SB-497115-GR
- Where
- 16 sites in Japan
- Volunteers
- 45 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
Telaprevir Open-Label Study in Co-Infected Patients
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated…
- Trial name
- NCT01500616
- Testing
- Telaprevir
- Where
- 29 sites in Belgium, Germany and 6 more
- Volunteers
- 122 people
- Sponsor
- Janssen-Cilag International NV