Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2010-10-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Placebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Interventions
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BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Placebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI443-012
Identifier Type: -
Identifier Source: org_study_id
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