Ph IIA Study (SOC +/- NS5B)

Phase 2

Completed

Interventions: Drug: BMS-791325
Drug: Placebo
Drug: Peg-interferon alfa-2a
Drug: Ribavirin

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-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	BMS-791325	-
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin	Placebo	-
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	BMS-791325	-
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	Peg-interferon alfa-2a	-
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	Ribavirin	-
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	Peg-interferon alfa-2a	-
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin	Ribavirin	-
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin	Peg-interferon alfa-2a	-
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)	Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR	Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA	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	Week 24
Resistant HCV variants associated with virologic failure	End of treatment (Week 48) or upon early discontinuation
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA	Week 4

Locations (10): Options Health Research, Llc
🇺🇸
Tulsa, Oklahoma, United States
Advanced Clinical Research Institute
🇺🇸
Anaheim, California, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Claudia T. Martorell, Md, Llc
🇺🇸
Springfield, Massachusetts, United States
Charlotte Gastroenterology & Hepatology, Pllc
🇺🇸
Charlotte, North Carolina, United States
Metropolitan Research
🇺🇸
Fairfax, Virginia, United States
Digestive Disease Associates, P.A.
🇺🇸
Baltimore, Maryland, United States
Mercy Medical Center
🇺🇸
Baltimore, Maryland, United States
The North Texas Research Institute
🇺🇸
Arlington, Texas, United States
Alamo Medical Research
🇺🇸
San Antonio, Texas, United States