Status:
WITHDRAWN
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrate...
Eligibility Criteria
Inclusion
- Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
- HCV RNA viral load ≥ 10,000 IU/mL
- Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
- Patients with compensated cirrhosis are permitted
Exclusion
- Infected with HCV other than GT 1 or 4
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
- Evidence of a medical condition contributing to chronic liver disease other than HCV
- History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- Laboratory values:
- Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males)
- Platelets \< 90 x 1000000000 cells/L
- Absolute neutrophil count (ANC) \< 1.5 × 1000000000 cells/L
- Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01797848
Start Date
June 1 2014
End Date
November 1 2016
Last Update
November 25 2013
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