Ph IIA Study (SOC +/- NS5B)
Completed · Phase 2 · Has a placebo group
Conditions studied: Hepatitis C Virus
In brief
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-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
Key facts
- Study ID
- NCT01193361
- Run by
- Bristol-Myers Squibb
- People needed
- 39
- Starts
- 2010-10-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2015-10-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Advanced Clinical Research Institute — Anaheim, California, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Digestive Disease Associates, P.A. — Baltimore, Maryland, United States
- Claudia T. Martorell, Md, Llc — Springfield, Massachusetts, United States
- Charlotte Gastroenterology & Hepatology, Pllc — Charlotte, North Carolina, United States
- Options Health Research, Llc — Tulsa, Oklahoma, United States
- The North Texas Research Institute — Arlington, Texas, United States
- Alamo Medical Research — San Antonio, Texas, United States
- Metropolitan Research — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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