Clinical trials: Hepatic Disease
Hepatitis B
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
- Trial name
- NCT00412750
- Testing
- Telbivudine (LdT), peginterferon alpha-2a
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Novartis
Hepatitis C, Chronic, Healthy Volunteer
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01181024
- Testing
- RO5303253
- Where
- New Zealand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis A, Hep A
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2…
- Trial name
- NCT05613127
- Testing
- Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL, HAVRIX 720 Junior 0.5 mL
- Where
- 2 sites in South Korea, Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Hepatitis C
Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon.
- Trial name
- NCT03537274
- Testing
- PEG-Intron, Interferon Alfa-2B
- Volunteers
- 1,224 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
- Conditions
- Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- Trial name
- NCT02834780
- Testing
- H3B-6527
- Where
- 44 sites in United States, Belgium and 9 more
- Volunteers
- 128 people
- Sponsor
- H3 Biomedicine Inc.
Non-alcoholic Fatty Liver Disease
Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome
The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with…
- Trial name
- NCT02930161
- Testing
- Runihol
- Where
- 3 sites in Russia
- Volunteers
- 35 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Hepatitis C
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy…
- Trial name
- NCT02095860
- Testing
- DCV 3DAA FDC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Inborn Errors of Bile Acid Synthesis
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital…
- Trial name
- NCT01115582
- Testing
- Cholic acid
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis C, Chronic
Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C.
GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment of chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT02014571
- Testing
- GSK2878175
- Where
- Puerto Rico
- Volunteers
- 37 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)
This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment…
- Trial name
- Pegade (NCT00237484)
- Testing
- Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin, Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
- Volunteers
- 89 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection
The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.
- Trial name
- CERTAIN-2 (NCT02723084)
- Testing
- ABT-493/ABT-530, sofosbuvir (SOF), ribavirin (RBV)
- Volunteers
- 136 people
- Sponsor
- AbbVie
Hypertension, Vascular Diseases
SPYRAL GEMINI Pilot Study
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SPYRAL GEMINI (NCT06907147)
- Testing
- Multi-Organ Denervation Gemini System
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 175 people
- Sponsor
- Medtronic Vascular
Chronic Hepatitis B
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers.
- Trial name
- NCT03714152
- Testing
- ABI-H2158
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
NASH, MASH
ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks.
- Conditions
- NASH, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis
- Trial name
- HERALD (NCT06342947)
- Testing
- ALG-055009
- Where
- 40 sites in United States
- Volunteers
- 102 people
- Sponsor
- Aligos Therapeutics
Hepatitis B, Chronic
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT00940485
- Testing
- entecavir, peginterferon alfa-2a [Pegasys]
- Where
- 7 sites in China
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Hepatocellular Carcinoma
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.
- Trial name
- Shelter (NCT00943449)
- Testing
- 4SC-201, Sorafenib
- Where
- 15 sites in Germany, Italy
- Volunteers
- 57 people
- Sponsor
- 4SC AG
Chronic Hepatitis B
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable…
- Trial name
- NCT00393484
- Testing
- Entecavir, Lamivudine
- Where
- 15 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
- Trial name
- NCT04942964
- Testing
- Bocidelpar
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)
This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.
- Trial name
- NCT03365921
- Testing
- Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
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