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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

2015-03-10 01:53:24 | BioPortfolio

Summary

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 treatment of Hepatitis C in patients who have not responded to prior therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Hepatitis C

Intervention

BMS-790052, BMS-650032, BMS-650032, BMS-650032, Pegylated-interferon alfa-2a, Ribavirin

Location

Advanced Clinical Research Institute
Anaheim
California
United States
92801

Status

Completed

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-10T01:53:24-0400

Clinical Trials [1350 Associated Clinical Trials listed on BioPortfolio]

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient ac...

Drug-Drug Interaction Study in Healthy Subjects

The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone

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.

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

PubMed Articles [875 Associated PubMed Articles listed on BioPortfolio]

Population PK-PD model of pegylated interferon alfa-2a in healthy Korean men.

Pegylated interferon alfa-2a (PEG-IFN alfa-2a), which was developed to overcome the disadvantages of conventional formulations, is widely prescribed for hepatitis B or C virus infection. It is charact...

Effect of Direct-Acting Agents on Fibrosis Regression in Chronic Hepatitis C Virus Patients' Treatment Compared with Interferon-Containing Regimens.

Hepatitis C virus (HCV) treatment is aiming to cure and prevent the development, progression of fibrosis, and related complications. Interferon-based therapy was claimed to reduce or even reverse fibr...

Ribavirin therapy of hepatitis E infection may cause hyporegenerative anemia in pediatric renal transplant patients.

HEV infection can lead to chronic hepatitis in immunosuppressed patients; extrahepatic manifestations are rarely seen. Here, we report a 13-year-old renal transplant patient with chronic hepatitis E a...

Early development of de novo hepatocellular carcinoma after direct-acting agent therapy: comparison with pegylated interferon-based therapy in chronic hepatitis C patients.

Patients with chronic hepatitis C who achieve a sustained viral response after pegylated interferon therapy have a reduced risk of hepatocellular carcinoma, but the risk after treatment with direct-ac...

A highly bioactive Lys-deficient IFN leads to a site-specific di-PEGylated IFN with equivalent bioactivity to that of unmodified IFN-α2b.

Although conjugation with polyethylene glycol (PEGylation) improves the pharmacokinetics of therapeutic proteins, it drastically decreases their bioactivity. Site-specific PEGylation counters the redu...

Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.

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