Clinical trials: Hepatitis C Infection
Healthy Male Participants
A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients
The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics (what the body does to the medication) of simeprevir (TMC435) after administration of single oral doses of 50 mg and 150 mg when…
- Trial name
- NCT01707342
- Testing
- Simeprevir (TMC435)
- Where
- Belgium
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Hepatitis C
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. Registration for license application
- Trial name
- NCT01582594
- Where
- 4 sites in China
- Volunteers
- 795 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical, China
HCV Infection
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV
The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies how the body processes a drug), and initial activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by…
- Trial name
- NCT00725803
- Testing
- GS-9450
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 33 people
- Sponsor
- Gilead Sciences
Healthy Volunteer
TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers.
- Trial name
- NCT01288677
- Testing
- TMC649128
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Recurrent Chronic Hepatitis C Virus, Post Liver Transplant
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C.
- Trial name
- NCT01687270
- Testing
- Sofosbuvir, RBV
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Hepatitis C
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver…
- Trial name
- NCT02551861
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 12 sites in Canada, France
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C Infection, Hepatitis C
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in…
- Conditions
- Chronic Hepatitis C Infection, Hepatitis C, Hepatitis C Virus
- Trial name
- NCT01306617
- Testing
- ABT-450, ABT-333, ribavirin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
- Trial name
- NCT01389323
- Testing
- Daclatasvir, Peg-Interferon Alfa-2a, Ribavirin
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 448 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Hepatitis C, Chronic
Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver…
- Trial name
- NCT00039962
- Testing
- thymalfasin (thymosin alpha 1), PEGinterferon alfa-2a
- Where
- 56 sites in United States, Puerto Rico
- Volunteers
- 500 people
- Sponsor
- SciClone Pharmaceuticals
Hepatitis C, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1…
- Trial name
- PEGHOPE (NCT01416610)
- Where
- 10 sites in Austria
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Liver Disease
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination…
- Trial name
- NCT02094443
- Testing
- Alisporivir, Ribavirin
- Where
- 16 sites in United States, France
- Volunteers
- 52 people
- Sponsor
- Debiopharm International SA
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV)…
- Trial name
- NCT02251717
- Testing
- LDV/SOF
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 114 people
- Sponsor
- Gilead Sciences
Hepatitis C
Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.
This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit.
- Trial name
- NCT00833378
- Testing
- Eltrombopag, Lopinavir/Ritonavir, Eltrombopag and Lopinavir/Ritonavir
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1.
- Trial name
- NCT00115908
- Testing
- Albuferon, Ribavirin, PEG-IFNalfa2a
- Where
- 87 sites in Australia, Canada and 6 more
- Volunteers
- 458 people
- Sponsor
- Human Genome Sciences Inc.
Hepatitis C Virus Infection
Safety and Efficacy Study in Hepatitis C Patients With PHN121
To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients
- Trial name
- ENCHAMP (NCT01052090)
- Testing
- PHN121
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- PhytoHealth Corporation
Chronic Hepatitis C
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Trial name
- NCT01817985
- Testing
- GS-5816
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatitis C
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in…
- Trial name
- NCT00984620
- Testing
- BI 201335, Pegylated Interferon-alpha (IFN), Ribavirin (RBV)
- Where
- 28 sites in United States, Austria and 4 more
- Volunteers
- 160 people
- Sponsor
- Boehringer Ingelheim
HCV Infection
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying…
- Trial name
- NCT03379506
- Testing
- EBR/GZR FDC Tablet, Grazoprevir Oral Granules, Elbasvir Oral Granules
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic, Hepatitis C
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic.
- Trial name
- NCT00723632
- Testing
- peginterferon alfa-2b, ribavirin
- Volunteers
- 901 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants…
- Trial name
- NCT02021656
- Testing
- LDV/SOF
- Where
- 45 sites in China, South Korea and 1 more
- Volunteers
- 384 people
- Sponsor
- Gilead Sciences
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