Clinical trials: Liver Diseases
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks…
- Trial name
- NCT02350569
- Testing
- LDV/SOF
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Gilead Sciences
Advanced Cancer, Angiosarcoma
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1…
- Conditions
- Advanced Cancer, Angiosarcoma, Colorectal Cancer Without Liver Metastases, Endometrial Cancer
- Trial name
- NCT03860272
- Testing
- Botensilimab, Balstilimab
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 499 people
- Sponsor
- Agenus Inc.
Hepatitis C Virus
TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)
The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the…
- Trial name
- NCT01323257
- Testing
- erythromycin, Ritonavir, TMC435
- Where
- Belgium
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis B
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and…
- Trial name
- NCT02431312
- Testing
- INO-1800, INO-9112, Nucleos(t)ide Analogue Treatment
- Where
- 22 sites in United States, Australia and 6 more
- Volunteers
- 90 people
- Sponsor
- Inovio Pharmaceuticals
Viral Hepatitis Vaccines, Hepatitis A
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus
- Trial name
- NCT01160081
- Testing
- Serum sample
- Where
- Mexico
- Volunteers
- 3,658 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Severe Hepatic Veno-Occlusive Disease
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of…
- Trial name
- NCT00358501
- Testing
- Defibrotide
- Where
- 25 sites in United States, Canada
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Chronic Hepatitis C
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT01826981
- Testing
- LDV/SOF, SOF, RBV
- Where
- 2 sites in New Zealand
- Volunteers
- 359 people
- Sponsor
- Gilead Sciences
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Non-Alcoholic Fatty Liver Disease (NAFLD)
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD.
- Trial name
- NCT03776175
- Testing
- PF-05221304 Monotherapy, PF-06865571 Monotherapy, PF-05221304 and PF-06865571 Combination
- Where
- 29 sites in United States
- Volunteers
- 99 people
- Sponsor
- Pfizer
Cachexia, Hepatocellular Carcinoma
Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma
This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with…
- Trial name
- NCT07356037
- Testing
- Nanocrystalline Megestrol Acetate, Standard Antitumor Therapy
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Chronic Hepatitis B
A Study to Evaluate the Mass Balance Absorption and AME of VBR
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
- Trial name
- NCT04637139
- Testing
- Vebicorvir (VBR)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Hepatitis B
Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus
The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).
- Trial name
- NCT00305019
- Testing
- clevudine
- Where
- 8 sites in South Korea
- Volunteers
- 120 people
- Sponsor
- Bukwang Pharmaceutical
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Hepatitis B Virus
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs.
- Trial name
- NCT00805675
- Testing
- Telbivudine, Tenofovir, Telbivudine plus tenofovir
- Where
- China
- Volunteers
- 83 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
- Trial name
- NCT04774107
- Testing
- P1101 + Ribavirin
- Where
- 5 sites in Taiwan
- Volunteers
- 17 people
- Sponsor
- PharmaEssentia
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
Chronic Hepatitis B
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects.
- Trial name
- NCT05569941
- Testing
- ABI-4334 Tablet
- Where
- New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Hepatitis D, Chronic
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD).
- Trial name
- NCT02732639
- Testing
- Pegylated Interferon (PEG-IFN) alfa-2a
- Where
- 7 sites in Romania
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
- Trial name
- NCT02287857
- Testing
- Domestic Tenofovir Disoproxil Fumarate Tablets, Tenofovir Disoproxil Fumarate Tablets of Gilead
- Where
- 15 sites in China
- Volunteers
- 360 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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