Status:
COMPLETED
Ph IIA Study (SOC +/- NS5B)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naï...
Eligibility Criteria
Inclusion
- Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
- HCV RNA ≥ 10\*5\* IU/mL at Screening
- Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
- Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² at Screening
Exclusion
- Liver transplant recipients
- Documented or suspected HCC by imaging or liver biopsy
- Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01193361
Start Date
October 1 2010
End Date
November 1 2012
Last Update
October 9 2015
Active Locations (10)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
Mercy Medical Center
Baltimore, Maryland, United States, 21202
4
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229