Clinical trials: Liver Diseases
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Trial name
- NCT05775159
- Testing
- Volrustomig, Bevacizumab, Lenvatinib
- Where
- 46 sites in United States, China and 7 more
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Chronic Kidney Disease
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD)…
- Trial name
- NCT01282762
- Testing
- HEPLISAV, Engerix-B
- Where
- United States
- Volunteers
- 147 people
- Sponsor
- Dynavax Technologies Corporation
Hepatocellular Carcinoma
Phase I Safety Study of Dendritic Cell Vaccine to Treat Patients With Hepatocellular Carcinoma
The primary objective of this study is to answer the question "Is it possible to inject the COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects"?
- Trial name
- NCT01974661
- Testing
- COMBIG-DC (ilixadencel)
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Mendus
Liver Tumors, HCC - Hepatocellular Carcinoma
Needle-based Percutaneous Ablation of Liver Tumors.
The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are: 1.
- Conditions
- Liver Tumors, HCC - Hepatocellular Carcinoma, Metastatic Liver Tumor
- Trial name
- NCT06689670
- Testing
- Needle based delivery of INT001 into liver tumors under real-time image guidance
- Where
- Turkey (Türkiye)
- Volunteers
- 31 people
- Sponsor
- inTumo Therapeutics, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04140123
- Testing
- ZSP1601
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Nonalcoholic Steatohepatitis
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT03987074
- Testing
- Semaglutide, Firsocostat, Cilofexor
- Where
- 18 sites in United States
- Volunteers
- 109 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic, Hepatitis C Virus
Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.
- Trial name
- NCT00705224
- Testing
- Pegylated Interferon, Ribavirin
- Volunteers
- 250 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
Acute Decompensation of Liver Cirrhosis, Established Acute-on-Chronic Liver Failure
Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients with Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
- Trial name
- CONTROL-ACLF (NCT07694297)
- Testing
- NTZ 500mg BID on top of SOC
- Volunteers
- 16 people
- Sponsor
- Genfit
Carcinoma, Hepatocellular
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With…
- Trial name
- NCT06349980
- Testing
- HLX53 (1000mg), HLX53 (2000mg), HLX10
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Shanghai Henlius Biotech
Carcinoma, Hepatocellular
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer.
- Trial name
- NCT00699374
- Testing
- sunitinib malate, sorafenib
- Where
- 171 sites in United States, Australia and 21 more
- Volunteers
- 1,075 people
- Sponsor
- Pfizer
Hepatic Insufficiency, Liver Diseases
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
- Trial name
- NCT07559474
- Testing
- INCB123667
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Nonalcoholic Steatohepatitis (NASH)
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NASH (NCT04134091)
- Testing
- LPCN 1144 Formulation A, LPCN 1144 Formulation B
- Where
- 19 sites in United States
- Volunteers
- 56 people
- Sponsor
- Lipocine Inc.
Hepatitis C, Chronic
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C.
- Trial name
- NCT00940420
- Testing
- Copegus (ribavirin), peginterferon alfa-2a [Pegasys]
- Where
- 20 sites in Israel
- Volunteers
- 2,695 people
- Sponsor
- Hoffmann-La Roche
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis B Virus (HBV)
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT00734162
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 21 sites in United States, Bulgaria and 5 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment.
- Trial name
- NCT07290257
- Testing
- Livmarli Oral Product
- Where
- 15 sites in Belgium, France and 6 more
- Volunteers
- 230 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis C, Chronic
A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic…
- Trial name
- COMMIT (NCT02268864)
- Testing
- Simeprevir, Daclatasvir
- Where
- 23 sites in Belgium, France and 4 more
- Volunteers
- 106 people
- Sponsor
- Janssen-Cilag International NV
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