Clinical trials: Hepatic Disease
Hepatic Insufficiency
Study of Telaprevir in Subjects With Hepatic Impairment
The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.
- Trial name
- NCT00509210
- Testing
- telaprevir (VX-950)
- Where
- United States
- Sponsor
- Vertex Pharmaceuticals Incorporated
Ovarian Cancer, Pancreas Cancer
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma.
- Conditions
- Ovarian Cancer, Pancreas Cancer, Urothelial Carcinoma, Renal Cell Carcinoma
- Trial name
- NCT06582017
- Testing
- QXL138AM Injection every 2 weeks by IV Infusion
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- Nammi Therapeutics Inc
Advanced Malignancies
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose.
- Trial name
- NCT03474640
- Testing
- Part A, Part B
- Where
- 14 sites in United States
- Volunteers
- 184 people
- Sponsor
- TopAlliance Biosciences
Chronic Hepatitis C
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1).
- Trial name
- NCT01590225
- Testing
- Boceprevir, Peginterferon alpha-2b, Ribavirin
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600 mg BID of filibuvir in healthy women and to…
- Trial name
- NCT00918476
- Testing
- filibuvir + Oral Contraceptives
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1.
- Trial name
- NCT04001608
- Testing
- Seraprevir, Sofosbuvir
- Where
- 22 sites in China
- Volunteers
- 206 people
- Sponsor
- Ginkgopharma CO., LTD
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Hepatitis B
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
- Trial name
- NCT04499443
- Testing
- GST-HG131 tablets
- Where
- China
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Fujian Cosunter Pharmaceutical Co. Ltd
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Carcinoma, Hepatocellular
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
The purpose of the study is Find out if patients receiving Sorafenib will live longer Find out if Sorafenib has any effect on patient reported outcomes Find out if Sorafenib prevents the growth or shrinks liver tumors and / or…
- Trial name
- NCT00492752
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 23 sites in China, South Korea and 1 more
- Volunteers
- 226 people
- Sponsor
- Bayer
Liver Disease
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
- Trial name
- NCT01370148
- Testing
- conivaptan hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Hepatitis B, Chronic
Efficacy and Safety of TAF in Patients With Suboptimal Response to Other Nucleos(t)Ides
Both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are potent antiviral agents for hepatitis B virus (HBV) and recommended by the American Association for the Study of Liver Disease (AASLD) as well as the…
- Trial name
- NCT04201808
- Testing
- Tenofovir Alafenamide 25 MG
- Where
- 10 sites in China
- Volunteers
- 100 people
- Sponsor
- New Discovery LLC
Hepatitis C, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients…
- Trial name
- NCT01750216
- Where
- 14 sites in Poland
- Volunteers
- 196 people
- Sponsor
- Hoffmann-La Roche
Whole Cell Pertussis, Haemophilus Influenzae Type b
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of…
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria
- Trial name
- NCT00136604
- Testing
- Tritanrix-HepB/Hib-MenAC, Mencevax ACWY, Tritanrix-HepB/Hiberix
- Where
- 3 sites in Thailand
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients
This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic…
- Trial name
- NCT00801255
- Testing
- RO5024048, danoprevir
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus
Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06961643
- Testing
- HRS-7535 Tables
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Hepatitis C, Liver Disease
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e.
- Trial name
- NCT01970904
- Testing
- Alisporivir, Ribavirin, Peg-IFNα2a
- Where
- 25 sites in Germany, Poland and 2 more
- Volunteers
- 147 people
- Sponsor
- Debiopharm International SA
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Oncology, Interventional Radiology
Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy
This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue…
- Conditions
- Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma
- Trial name
- NCT07046832
- Testing
- Augmented Reality Guided Biopsy, Ultrasound Guided Biopsy
- Where
- 3 sites in United States
- Volunteers
- 104 people
- Sponsor
- MediView XR, Inc.
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