Clinical trials: Cirrhosis
Liver Fibrosis, Hepatic Cirrhosis
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis.
- Trial name
- BORANA (NCT06750276)
- Testing
- AZD2389
- Where
- 9 sites in United States, Puerto Rico and 1 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Liver Disease
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
- Trial name
- MBT (NCT00736840)
- Testing
- c13 methacetin solution with breath analyzer
- Where
- 11 sites in United States, Israel
- Volunteers
- 414 people
- Sponsor
- Meridian Bioscience, Inc.
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc
Hepatitis C, Chronic
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic…
- Trial name
- NCT02765490
- Testing
- AL-335, Odalasvir, Simeprevir
- Where
- 28 sites in Belgium, Canada and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
Esophageal and/or Gastric Varices
Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices
The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding.
- Trial name
- NCT00161915
- Testing
- Fibrin Sealant
- Where
- 12 sites in Germany
- Sponsor
- Baxter Healthcare Corporation
Cirrhosis
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in…
- Trial name
- NCT00479336
- Testing
- OPC-41061 7.5mg, OPC-41061 15mg, OPC-41601 30mg
- Where
- 7 sites in Japan
- Volunteers
- 104 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Primary Biliary Cholangitis, Compensated Cirrhosis
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
- Trial name
- NCT06525311
- Testing
- K-808
- Where
- 10 sites in United States, Japan
- Volunteers
- 17 people
- Sponsor
- Kowa Research Institute, Inc.
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
Chronic Liver Disease, Cirrhosis
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
The purpose of this study is to determine the effect on the (carbon 13 labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker (NSBB) following initial administration and after chronic use of…
- Conditions
- Chronic Liver Disease, Cirrhosis, Esophageal Varices, Portal Hypertension
- Trial name
- NCT01851252
- Testing
- Methacetin (with Breath testing device)
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C Infection
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects…
- Trial name
- GIFT I (NCT02023099)
- Testing
- ABT-450/r/ABT-267
- Volunteers
- 363 people
- Sponsor
- AbbVie
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection…
- Trial name
- EXPEDITION-5 (NCT03069365)
- Testing
- Glecaprevir/pibrentasvir
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Liver Cirrhoses
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.
- Trial name
- NCT04357600
- Testing
- Allogeneic Umbilical Cord Mesenchymal Stem Cell
- Where
- Indonesia
- Volunteers
- 12 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
Decompensated Cirrhosis
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new…
- Trial name
- ENCORE-LF (NCT03205345)
- Testing
- Emricasan (25 mg), Emricasan (5 mg)
- Where
- 76 sites in United States
- Volunteers
- 210 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis C Virus (HCV)
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human…
- Trial name
- VOYAGE-2 (NCT03235349)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 34 sites in China, South Korea
- Volunteers
- 160 people
- Sponsor
- AbbVie
Liver Cirrhosis
A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
- Trial name
- NCT04088058
- Testing
- GXHPC1
- Where
- 2 sites in Taiwan
- Volunteers
- 20 people
- Sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
Non-Alcoholic Fatty Liver Disease
Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
- Trial name
- NCT04142749
- Testing
- Oltipraz
- Where
- 21 sites in South Korea
- Volunteers
- 146 people
- Sponsor
- PharmaKing
Liver Cirrhosis, Liver Diseases
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred…
- Conditions
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal
- Trial name
- NCT04668664
- Testing
- EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 70 people
- Sponsor
- Cook Research Incorporated