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Hepatitis C clinical trials

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NCT ID: NCT02115321 Completed - Chronic Hepatitis C Clinical Trials

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)

Start date: May 9, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.

NCT ID: NCT02114177 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

NCT ID: NCT02114151 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

NCT ID: NCT02113631 Completed - Cirrhosis Clinical Trials

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Start date: September 2011
Phase: N/A
Study type: Interventional

1. The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population. 2. The secondary objective: - Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

NCT ID: NCT02112110 Completed - Clinical trials for Hepatitis C Virus Infection

Absolute Bioavailability of BMS-791325

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

The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.

NCT ID: NCT02108639 Completed - Hepatitis C Clinical Trials

To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

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

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

NCT ID: NCT02107365 Completed - Clinical trials for Hepatitis C Virus Genotype 4 Infection

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Start date: November 2013
Phase: Phase 2
Study type: Interventional

Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment in non-responders genotype 1-infected patients. Given the absence of current solutions and urgent therapeutic needs for HCV genotype 4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir, Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat population. 60 subjects will be enrolled. The primary endpoint will be the rate of sustained virological response (SVR), defined by an undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).

NCT ID: NCT02106156 Completed - Chronic Hepatitis C Clinical Trials

Observational Study Evaluating the Quality of Pegasys and Copegus Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Start date: January 2008
Phase: N/A
Study type: Observational

This observational study will examine the efficacy and safety of Pegasys (peginterferon alfa-2a), mostly in combination with Copegus (ribavirin) treatment in CHC patients. Quality of care will also be assessed. Approximately 12% of the interferon-treated chronic hepatitis C (CHC) patient population in Germany is expected to be studied over a period of 5 years.

NCT ID: NCT02105701 Completed - Clinical trials for Hepatitis C Infection

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)

Start date: June 5, 2014
Phase: Phase 3
Study type: Interventional

This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.

NCT ID: NCT02105688 Completed - Chronic Hepatitis C Clinical Trials

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)

C-EDGE CO-STAR
Start date: September 2, 2014
Phase: Phase 3
Study type: Interventional

This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a 3-year observational follow-up.