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Hepatitis C clinical trials

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NCT ID: NCT02201940 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

ASTRAL-1
Start date: July 2014
Phase: Phase 3
Study type: Interventional

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 C virus (HCV) infection.

NCT ID: NCT02201901 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

ASTRAL-4
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

NCT ID: NCT02196064 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects

Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."

hEPAtic
Start date: May 2014
Phase: N/A
Study type: Observational

To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.

NCT ID: NCT02195440 Completed - Clinical trials for Hepatitis C Virus-infected Cirrhosis

An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.

NCT ID: NCT02185794 Completed - Clinical trials for Hepatitis C Virus Infection

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection

Start date: June 13, 2014
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.

NCT ID: NCT02176980 Completed - Clinical trials for Hepatitis C, Chronic; AUD

Hepatitis C Alcohol Reduction Treatment

HepART-RCT
Start date: October 2014
Phase: N/A
Study type: Interventional

Subjects are being asked to take part in a research study to test two levels of alcohol services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ in intensity of alcohol services and in whether or not they include a focus on liver health. The study will look at which level of alcohol services best decreases alcohol use among patients with HCV.

NCT ID: NCT02176525 Completed - Clinical trials for Hepatitis C, Chronic

Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients

Start date: December 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.

NCT ID: NCT02175966 Completed - Hepatitis C Clinical Trials

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

FOURward
Start date: July 28, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

NCT ID: NCT02175758 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Start date: July 7, 2014
Phase: Phase 2
Study type: Interventional

This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.

NCT ID: NCT02175602 Completed - Clinical trials for Hepatitis C Infection

Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Start date: June 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.