An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Hepatitis C Infection Clinical Trial

Official title:

A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051414
• Other study ID #: AI447-017
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: September 23, 2015
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects chronically infected with HCV Genotype 1

• HCV RNA viral load of = 10*5* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria:

• Subjects with evidence of liver cirrhosis

• Evidence of HCC

• Co-infection with hepatitis B virus, HIV

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Infection

Intervention

Drug:
• BMS-790052
Tablets, Oral, 60 mg, daily, 24 weeks
• BMS-650032
Tablets, Oral, 1200 mg, daily, 24 weeks

Locations

Country	Name	City	State
Japan	Local Institution	Hiroshima City	Hiroshima
Japan	Local Institution	Kawasaki-Shi	Kanagawa
Japan	Local Institution	Minato-Ku	Tokyo
Japan	Local Institution	Sapporo-Shi	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs		Week 4	Yes
Primary	Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)		Post-treatment Week 12	Yes
Secondary	The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities		Weeks 4, 12, end of treatment and post-treatment Week 24	Yes
Secondary	The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL		Week 4	No
Secondary	The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL		at both Weeks 4 and 12	Yes
Secondary	The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL		at follow-up Week 24	Yes
Secondary	Resistant variants associated with clinical failure		Weeks 4, 12, end of treatment and post-treatment Week 24	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form