Clinical trials: Hepatic Disease
Chronic Genotype 1 Hepatitis C Virus Infection
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
- Trial name
- NCT01247194
- Testing
- PPI-461
- Where
- 11 sites in United States, Denmark and 1 more
- Volunteers
- 24 people
- Sponsor
- Presidio Pharmaceuticals, Inc.
Vaccine Exposure During Pregnancy
PREHEVBRIO Pregnancy Outcomes Registry
The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to…
- Trial name
- NCT06097312
- Testing
- Data collection
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Hepatitis A, Hepatitis B
Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult
This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline (GSK) Biologicals' Twinrix…
- Trial name
- NCT01000324
- Testing
- Blood sampling, Engerix-B, Havrix
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Age-Related Macular Degeneration, Allergies
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and…
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease
- Trial name
- NCT05635266
- Testing
- Specimen sample
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Sanguine Biosciences
Acute Intermittent Porphyria
A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)
The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.
- Trial name
- NCT02452372
- Testing
- givosiran (ALN-AS1), Sterile Normal Saline (0.9% NaCl)
- Where
- 6 sites in United States, Sweden and 1 more
- Volunteers
- 40 people
- Sponsor
- Alnylam Pharmaceuticals
Portal Hypertension
Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications
The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the…
- Trial name
- NCT06320912
- Testing
- The intraparenchymal portal vein covered stent, TIPS Covered Stent System GORE
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Nonalcoholic Steatohepatitis
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.
- Trial name
- NCT03676231
- Testing
- SGM-1019
- Where
- 10 sites in United States
- Volunteers
- 9 people
- Sponsor
- Second Genome
Chronic Hepatitis B
REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection
NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients.
- Trial name
- NCT02565719
- Testing
- REP 2139-Mg, Pegasys, Viread
- Where
- 3 sites in Moldova
- Volunteers
- 40 people
- Sponsor
- Replicor Inc.
Hepatitis B
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine.
- Trial name
- NCT00366366
- Testing
- Infanrix-Hexa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Polio
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
- Conditions
- Diphtheria, Polio, Pertussis, Hepatitis B
- Trial name
- NCT00619502
- Testing
- DTaP-IPV-HB-PRP~T vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatocellular Carcinoma
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or…
- Trial name
- NCT05862337
- Testing
- Anlotinib hydrochloride capsules, Penpulimab injection
- Where
- 67 sites in China
- Volunteers
- 480 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B, Chronic
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China.
- Trial name
- PK of TDF (NCT01480622)
- Testing
- TDF tablets
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Study of AHB-171 in Chronic Hepatitis B Participants
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB).
- Trial name
- EXTEND-101 (NCT07617194)
- Testing
- AHB-171, Nucleos(t)ide Analogue (NA)
- Where
- 2 sites in Hong Kong, New Zealand
- Volunteers
- 144 people
- Sponsor
- AusperBio Therapeutics Inc.
Hepatocellular Carcinoma (HCC), Solid Malignancies
FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid…
- Trial name
- NCT02325739
- Testing
- FGF401, PDR001
- Where
- 27 sites in United States, China and 9 more
- Volunteers
- 172 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
- Trial name
- NCT02964910
- Testing
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Liver Cirrhosis
Alfapump-albumin Replacement Therapy
The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients.
- Trial name
- NCT02448160
- Testing
- alfapump, salt-poor Human Albumin solution
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Sequana Medical N.V.
Carcinoma, Hepatocellular
A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
The purpose of this study is to characterize the preliminary antitumor activity of amivantamab at the recommended dose in participants with previously systemically treated hepatocellular carcinoma (HCC)
- Trial name
- NCT05653427
- Testing
- Amivantamab
- Where
- 13 sites in China
- Volunteers
- 18 people
- Sponsor
- Janssen Research & Development, LLC
Hepatocellular Carcinoma
Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a second line treatment in subjects with advanced Hepatocellular Carcinoma.
- Trial name
- NCT02267213
- Testing
- Lipotecan
- Where
- 12 sites in China, Taiwan
- Volunteers
- 29 people
- Sponsor
- Taiwan Liposome Company
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