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Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2b and Ribavirin)

2014-08-27 03:17:50 | BioPortfolio

Summary

The purpose of this study is to identify at least 1 dose of BMS-790052, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hepatitis C Infection

Intervention

BMS-790052, BMS-790052, Placebo, Peginterferon alfa-2b, Ribavirin

Location

Local Institution
Hiroshima City
Hiroshima
Japan
734-0037

Status

Active, not recruiting

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:50-0400

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A Multiple Ascending Dose Study of BMS-790052 in Hepatitis C Virus (HCV) Infected Subjects

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Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the tr...

A Single Ascending Dose Study of BMS-790052 in HCV Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-790052 in subjects with chronic hepatitis C infection

An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)

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An easy-to-use baseline scoring system to predict response to peginterferon alfa-2a in patients with chronic hepatitis B in resource-limited settings.

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No association between IFNL3 (IL28B) genotype and response to peginterferon alfa-2a in HBeAg-positive or -negative chronic hepatitis B.

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Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

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