Clinical trials: Hepatitis C Infection
Chronic Hepatitis C
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients…
- Trial name
- NCT00162734
- Testing
- Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
- Volunteers
- 144 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatitis C
Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)
This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor.
- Trial name
- OBSERVER (NCT01426204)
- Volunteers
- 40 people
- Sponsor
- Closter Pharma
Chronic Hepatitis C
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
- Trial name
- NCT00759200
- Testing
- alb-interferon alfa 2b, peg-interferon
- Where
- 55 sites in Australia, Canada and 10 more
- Volunteers
- 525 people
- Sponsor
- Novartis
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Cirrhosis, Chronic Hepatitis C
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy…
- Trial name
- NCT00502086
- Testing
- Viusid (nutritional supplement)
- Where
- Cuba
- Volunteers
- 100 people
- Sponsor
- Catalysis SL
Hepatitis C, Chronic
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination…
- Trial name
- NCT00081770
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908), PEGASYS (peginterferon alfa-2a)
- Volunteers
- 4,469 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy…
- Trial name
- NCT02508090
- Where
- Puerto Rico
- Volunteers
- 10 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short.
- Trial name
- NCT00351403
- Testing
- Ribavirin, Peginterferon alfa 2b
- Where
- 22 sites in Germany
- Volunteers
- 390 people
- Sponsor
- FGK Clinical Research GmbH
Hepatitis, Viral, Human
Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)
The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants.
- Trial name
- NCT01532973
- Testing
- Elbasvir
- Volunteers
- 48 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon…
- Trial name
- NCT01384383
- Testing
- GS-5885, GS-9451, RBV
- Where
- 55 sites in United States, Australia and 2 more
- Volunteers
- 248 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
- Trial name
- MAGNITUDE (NCT01741545)
- Testing
- Pegylated-Interferon-lambda, Ribavirin, Daclatasvir
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 71 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C…
- Trial name
- PEARL-I (NCT01685203)
- Testing
- ABT-450/r, ABT-267, Ribavirin (RBV)
- Volunteers
- 316 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Hepatitis C Virus
Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in…
- Trial name
- NCT02945228
- Where
- 170 sites in Japan
- Volunteers
- 449 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in…
- Trial name
- NCT01579019
- Testing
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys]
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.
- Trial name
- NCT00088140
- Testing
- IDN-6556
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis C, Chronic
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.
- Trial name
- NCT01508156
- Testing
- IDX719
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea…
- Trial name
- NCT02951364
- Testing
- LDV/SOF
- Where
- 72 sites in South Korea
- Volunteers
- 1,081 people
- Sponsor
- Gilead Sciences
Hepatitis C
A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2)…
- Trial name
- NCT03253471
- Testing
- AL-611
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Hepatitis C Virus
TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa.
- Trial name
- NCT01090700
- Testing
- TMC435, Escitalopram, TMC435 + Escitalopram
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
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