Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:3/4/2017
Start Date:June 2012
End Date:May 2015

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A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined
with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis
C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Data Monitoring Committee appointed for Part B

Masking:

Part A: Open Label Part B: Double Blind

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

Inclusion Criteria:

- Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects

- Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA)
based]

- Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on
prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL
after discontinuation of treatment). Capped at 20%

- HCV RNA ≥ 100,000 IU/mL

- Subjects with compensated cirrhosis can be enrolled and will be capped at
approximately 10%

- Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen
(HBsAg)

- Men or women, 18-70 years of age

Exclusion Criteria:

- Chronic liver disease due to causes other than chronic HCV

- Current or past evidence of decompensation

- Conditions that preclude the use of Alfa/RBV/TVR per respective labels

- Diagnosed or suspected hepatocellular carcinoma
We found this trial at
28
sites
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Annandale, Virginia 22031
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Arlington, Texas 76012
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Birmingham, Alabama 35233
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Garden Grove, California 92844
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Germantown, Tennessee 38138
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Kansas City, Missouri 64111
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Long Beach, California 90822
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Los Angeles, California 90073
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Marietta, Georgia 30060
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Newport News, Virginia 23602
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Norfolk, Virginia 23502
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Orlando, Florida 32803
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Saint Louis, Missouri 63110
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San Antonio, Texas 78215
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Torrance, California 90505
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Tulsa, Oklahoma 74137
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Tulsa, Oklahoma 74135
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