Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:March 2011
End Date:September 2014

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A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

The purpose of this study is to determine if combination therapy with Pegylated Interferon
Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or
BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)
compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48
weeks.

Study Classification: Pharmacokinetics/ Pharmacodynamics

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Chronic Hepatitis C, Genotype 1

- HCV RNA >100,000 IU/mL at screening;

- Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen
(HBsAg);

- Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and
will be capped at approximately 10%

Exclusion Criteria:

- Any evidence of liver disease other than HCV;

- Co-infection with HIV;

- Diagnosed or suspected hepatocellular carcinoma;

- Medical history or laboratory value abnormalities that would prohibit the use of
Pegylated Interferon Alpha-2a or Ribavirin
We found this trial at
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Palm Springs, California 92262
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Adelaide, South Australia
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Detroit, Michigan 48202
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Fairfax, Virginia 22031
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Fairfax, VA
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Houston, TX
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1101 East 33rd Street
Lutherville, Maryland 21093
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Lutherville, MD
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Manhasset, NY
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Phoenix, Arizona
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San Antonio, Texas 78215
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Statesville, North Carolina 28677
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Statesville, NC
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