Clinical trials: Hepatic Disease
Hypercholesterolemia
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
- Trial name
- NCT01670734
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- 2 sites in France, Moldova
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT01938430
- Testing
- LDV/SOF, RBV
- Where
- 30 sites in United States
- Volunteers
- 339 people
- Sponsor
- Gilead Sciences
Liver Cancer
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic…
- Trial name
- NCT01286428
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Pathfinder Therapeutics
Chronic Hepatitis B Infection
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have…
- Trial name
- NCT05355467
- Testing
- Tenofovir disoproxil fumarate, Historical Data
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Mylan (Taiwan) Ltd
Hepatitis B, Chronic
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus…
- Trial name
- NCT00962871
- Testing
- peginterferon alfa-2a [Pegasys], tenofovir
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma
Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
- Trial name
- NCT05317819
- Testing
- ADI-PEG20
- Where
- 11 sites in Taiwan, Vietnam
- Volunteers
- 300 people
- Sponsor
- Polaris Group
Hepatocellular Carcinoma, Liver Cancer
Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma
The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1…
- Trial name
- NCT07836530
- Testing
- BGB-B2033, Lenvatinib, Sorafenib
- Volunteers
- 492 people
- Sponsor
- BeOne Medicines
Hepatic Insufficiency
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
- Trial name
- NCT00781430
- Testing
- Neratinib (HKI-272)
- Where
- Russia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Erythropoietic Protoporphyria
Phase III Confirmatory Study in Erythropoietic Protoporphyria
This is a randomized placebo-controlled study to be conducted in two parallel study arms for a six month period (three doses). Between 75 and 100 eligible patients will be enrolled.
- Trial name
- NCT01605136
- Testing
- Afamelanotide
- Where
- 7 sites in United States
- Volunteers
- 93 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
Diphtheria, Tetanus
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00654901
- Testing
- DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
- Where
- 4 sites in Mexico
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatocellular Carcinoma, Squamous Cell Carcinoma of the Lung
BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
This is a first-in-human (FIH), Phase 1/2, open-label, multicenter study to assess safety and determine the recommended Phase 2 dose (RP2D) of BOXR1030 administration after lymphodepleting chemotherapy (LD chemotherapy) in…
- Conditions
- Hepatocellular Carcinoma, Squamous Cell Carcinoma of the Lung, Merkel Cell Carcinoma, Myxoid/Round Cell Liposarcoma
- Trial name
- DUET-1 (NCT05120271)
- Testing
- CAR-GPC3 T Cells
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Sotio Biotech Inc.
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with…
- Trial name
- NCT02114151
- Testing
- Simeprevir, Sofosbuvir
- Where
- 34 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Janssen Infectious Diseases BVBA
HCV Infection
Safety, Tolerability, and Antiviral Activity of 24 or 48 Weeks of GS-9190 in Combination With Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
The purpose of this study is to compare the safety, tolerability and effectiveness of the experimental drug GS-9190 when administered for 24 or 48 weeks with peginterferon alfa 2a and ribavirin for the treatment of genotype-1…
- Trial name
- NCT00743795
- Testing
- GS-9190, Peginterferon Alfa 2a, Ribavirin
- Where
- 72 sites in United States, Belgium and 5 more
- Volunteers
- 252 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
Hepatitis B virus (HBV) infection, especially chronic, is a significant worldwide medical problem. This is an exploratory study of the therapeutic mechanism of GSK3228836 in participants with chronic hepatitis B (CHB) on stable…
- Trial name
- B-Fine (NCT04544956)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus (HCV)
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon…
- Trial name
- NCT01447394
- Testing
- Pegylated Interferon Lambda, Pegylated Interferon Alfa-2a, Ribavirin
- Where
- 100 sites in United States, Canada and 18 more
- Sponsor
- Bristol-Myers Squibb
Alpha 1-Antitrypsin Deficiency, Emphysema
Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
- Trial name
- ELEVAATE (NCT05856331)
- Testing
- SAR447537, Zemaira
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 99 people
- Sponsor
- Sanofi
Carcinoma, Hepatocellular
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
The primary objective of this study is to evaluate the tolerability and safety of a combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).
- Trial name
- NCT03418922
- Testing
- Lenvatinib, Nivolumab
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Eisai Co., Ltd.
Cancer of Head and Neck, Lung Cancer, Nonsmall Cell
A Multicenter Cancer Biospecimen Collection Study
This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor…
- Conditions
- Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma
- Trial name
- NCT04510129
- Testing
- OncoPrism™ assay
- Where
- United States
- Volunteers
- 1,650 people
- Sponsor
- Cofactor Genomics, Inc.
Carcinoma, Hepatocellular
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
- Trial name
- GIDEON (NCT00812175)
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 75 sites in United States, Canada and 37 more
- Volunteers
- 3,371 people
- Sponsor
- Bayer
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