A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Hepatitis C Clinical Trial

Official title:

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497834
• Other study ID #: AI447-026
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2011
• Last updated: September 23, 2015
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic HCV-1b infected patient

• HCV RNA viral load of = 100,000 IU/mL at screening

• Ages 20 to 75 years

• Non-responder to Interferon plus Ribavirin therapy

• Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion Criteria:

Patients who have -

• Hepatocellular carcinoma

• Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)

• Severe or uncontrollable complication

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• BMS-790052 (Daclatasvir)
Tablets, Oral, 60mg, Once daily, 24 weeks
• BMS-650032 (Asunaprevir)
Capsules, Oral, 100mg, Twice daily, 24 weeks

Locations

Country	Name	City	State
Japan	Local Institution	Amagasaki-shi	Hyogo
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-shi	Yamanashi
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Hiroshima-shi	Hiroshima
Japan	Local Institution	Iruma-Gun	Saitama
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kanazawa-shi	Ishikawa
Japan	Local Institution	Kawasaki-Shi	Kanagawa
Japan	Local Institution	Kurume	Fukuoka
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Osaka-sayama-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sapporo-Shi	Hokkaido
Japan	Local Institution	Sendai-Shi	Miyagi
Japan	Local Institution	Shinagawa-ku	Tokyo
Japan	Local Institution	Suita	Osaka
Japan	Local Institution	Suita-shi	Osaka
Japan	Local Institution	Takamatsu-shi	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiviral activity, as determined by the proportion of subjects with SVR24	SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)	After 24 weeks of the last dose	No
Secondary	Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected		Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12	No
Secondary	Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected		Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24	No
Secondary	Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade		End of treatment plus 7 days	Yes
Secondary	Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]		Follow-up Week 24	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