JPRN-jRCT2080222042
Unknown
Phase 3
A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naive or Prior Relapsers to Alfa/RBV Therapy
Bristol-Myers K.K.0 sites450 target enrollmentMarch 14, 2013
ConditionsHepatitis C
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Bristol-Myers K.K.
- Enrollment
- 450
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients chronically infected with HCV Genotype\-1b
- •Naive to prior treatment or documented evidence of relapse after 48 weeks of treatment with alfa/Ribavirin (RBV)
- •HCV RNA viral load 100,000 copies/mL and more at screening
Exclusion Criteria
- •Infection with Hepatitis C virus (HCV) other than Genotype\-1b
- •Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)\-1/HIV\-2 antibody test at screening
- •Evidence of chronic liver disease caused by diseases other than chronic HCV infection
- •Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
- •Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- •Laboratory values:
- •1\.Hemoglobin \< 12\.0 g/dL (males) or \< 11\.0 g/dL (females)
- •2\.Platelets \< 90,000/mm3
- •3\.Total serum bilirubin 2 mg/dL and more (unless due to Gilbert's disease)
Outcomes
Primary Outcomes
Not specified
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