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
Marietta, Georgia 30060
1908
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Marietta, GA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
2101
mi
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Charlotte, NC
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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!...
1190
mi
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Fort Sam Houston, TX
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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...
13
mi
from 91732
Los Angeles, CA
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
2185
mi
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Orlando, FL
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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...
17
mi
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Anaheim, CA
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Annandale, Virginia 22031
2269
mi
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Annandale, VA
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Arlington, Texas 76012
1207
mi
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Arlington, TX
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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...
2302
mi
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Baltimore, MD
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1785
mi
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Birmingham, AL
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Birmingham, Alabama 35233
1785
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Birmingham, AL
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Garden Grove, California 92844
21
mi
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Garden Grove, CA
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Germantown, Tennessee 38138
1600
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Germantown, TN
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6130
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Graz,
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Kansas City, Missouri 64111
1340
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Kansas City, MO
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Long Beach, California 90822
21
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Long Beach, CA
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Los Angeles, California 90073
25
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Los Angeles, CA
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564
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Murray, UT
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Newport News, Virginia 23602
2321
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Newport News, VA
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Norfolk, Virginia 23502
2341
mi
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Norfolk, VA
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Orlando, Florida 32803
2186
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Orlando, FL
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Saint Louis, Missouri 63110
1570
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Saint Louis, MO
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San Antonio, Texas 78215
1189
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San Antonio, TX
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353
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San Francisco, CA
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2136
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Tampa, FL
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Torrance, California 90505
26
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Torrance, CA
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Tulsa, Oklahoma 74137
1253
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Tulsa, OK
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Tulsa, Oklahoma 74135
1253
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Tulsa, OK
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