EUCTR2010-022408-28-DK
Active, not recruiting
Not Applicable
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects with Chronic Hepatitis C Genotype 2 or 3 Infection+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0 dated 15-Oct-10)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 210
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed Written Informed Consent
- •2\) Target Population
- •a) Subjects chronically infected with either HCV genotype 2 or 3 (each HCV genotype will be capped at approximately 50% of the randomized study population), as documented by positive HCV RNA and anti\-HCV antibody at screening and either:
- •i) positive anti\-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening; or
- •ii) liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation);
- •b) No previous exposure to an interferon formulation (ie IFNa, pegIFNa) or RBV;
- •c) HCV RNA viral load of \= 100,000 IU/mL at screening;
- •d) Results of liver biopsy obtained \= 24 months prior to randomization demonstrating the presence or absence of cirrhosis; for compensated cirrhotics, results of liver biopsy documenting cirrhosis can be from any time period prior to randomization (compensated cirrhotics are capped at approximately 10% of randomized population);
- •e) Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI \= weight (kg)/\[height (m)]² at screening.
- •3\) Age and Reproductive Status
Exclusion Criteria
- •1\)Target Disease Exceptions
- •a)Infected with HCV other than genotype 2 or 3;
- •2\)Medical History \& Concurrent Diseases
- •a)Liver transplant recipients;
- •b)Documented or suspected HCC as evidence by imaging or liver biopsy;
- •c)Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria;
- •d)Evidence of medical condition associated with chronic liver disease other than HCV;
- •e)History of chronic HBV as documented by HBV serologies. Patients with resolved HBV infection may participate;
- •f)Current or known history of cancer within 5 years prior to enrollment;
- •g)Any gastrointestinal disease or surgical procedure that may impact study drug absorption;
Outcomes
Primary Outcomes
Not specified
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