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 |
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.
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
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
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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