Clinical trial NCT01193361: Ph IIA Study (SOC +/- NS5B)
Official title: A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Formal analysis at week 4 (and upon occurrence)
measure: Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Formal analysis at week 12 (and upon occurrence)
measure: Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Formal analysis at week 24 post treatment (and upon occurrence)
measure: Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Formal analysis at week 48 post treatment (and upon occurrence)
measure: Antiviral activity, as determined by the proportion subjects with eRVR
timeFrame: Week 4
measure: Antiviral activity, as determined by the proportion subjects with eRVR
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
timeFrame: Week 4
measure: Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
timeFrame: Week 12
measure: Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
timeFrame: Week 12
measure: Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
timeFrame: Week 24
measure: Resistant HCV variants associated with virologic failure
timeFrame: End of treatment (Week 48) or upon early discontinuation
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Springfield
country: United States
facility: Claudia T. Martorell, Md, Llc
state: Massachusetts
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, Pllc
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Arlington
country: United States
facility: The North Texas Research Institute
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: