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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Advanced Clinical Research Institute
Anaheim, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Mercy Medical Center
Baltimore, Maryland, United States
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 4 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 12 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 24 post treatment (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
Time frame: Week 4
Antiviral activity, as determined by the proportion subjects with eRVR
Time frame: Week 12
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Time frame: Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Time frame: Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time frame: Week 12
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Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
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
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time frame: Week 24
Resistant HCV variants associated with virologic failure
Time frame: End of treatment (Week 48) or upon early discontinuation