Ph IIA Study (SOC +/- NS5B)

Hepatitis C Virus Clinical Trial

— HEPCAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193361
• Other study ID #: AI443-012
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: September 23, 2015
• Start date: October 2010
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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, IFNa, pegIFNa-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)		Formal analysis at week 4 (and upon occurrence)	Yes
Primary	Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)		Formal analysis at week 12 (and upon occurrence)	Yes
Primary	Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)		Formal analysis at week 24 post treatment (and upon occurrence)	Yes
Primary	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)	Yes
Primary	Antiviral activity, as determined by the proportion subjects with eRVR		Week 4	Yes
Primary	Antiviral activity, as determined by the proportion subjects with eRVR		Week 12	Yes
Secondary	Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA		Week 4	No
Secondary	Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA		Week 12	No
Secondary	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 12	No
Secondary	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	No
Secondary	Resistant HCV variants associated with virologic failure		End of treatment (Week 48) or upon early discontinuation	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form