A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718145
• Other study ID #: AI447-031
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2012
• Last updated: September 23, 2015
• Start date: November 2012
• Est. completion date: December 2014

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 subject.

The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

Description:

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic HCV-1b infected patient

• HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening

• Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)

• Treatment naive subjects to Interferon (IFN) based therapy

• Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• Daclatasvir

• Asunaprevir

• Ribavirin

Biological:
• pegIFNa-2b

Drug:
• Telaprevir

Locations

Country	Name	City	State
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-shi	Yamanashi
Japan	Local Institution	Fukui
Japan	Local Institution	Fukuoka
Japan	Local Institution	Fukuoka
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Gifu
Japan	Local Institution	Hiroshima-shi	Hiroshima
Japan	Local Institution	Iruma-gun	Saitama
Japan	Local Institution	Izunokuni	Shizuoka
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kashihara	Nara
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Kumamoto
Japan	Local Institution	Kumamoto-shi	Kumamoto
Japan	Local Institution	Kurume	Fukuoka
Japan	Local Institution	Kyoto-shi	Kyoto
Japan	Local Institution	Matsumoto	Nagano
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nagasaki-shi	Nagasaki
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nagoya-shi
Japan	Local Institution	Nishinomiya-shi
Japan	Local Institution	Obihiro-shi	Hokkaido
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Omura	Nagasaki
Japan	Local Institution	Osaka
Japan	Local Institution	Osaka-sayama-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Saitama
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sendai-shi	Miyagi
Japan	Local Institution	Shimotsuke-shi	Tochigi
Japan	Local Institution	Shinagawa-ku	Tokyo
Japan	Local Institution	Suita	Osaka
Japan	Local Institution	Suita-shi	Osaka
Japan	Local Institution	Takamatsu-shi	Kagawa
Japan	Local Institution	Takasaki City	Gunma
Japan	Local Institution	Toyoake Shi	Aichi
Japan	Local Institution	Yamagata-shi	Yamagata
Japan	Local Institution	Yokohama-shi	Kanagawa
Japan	Local Institution	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort	SVR12 = Sustained virologic response at post-treatment Week 12; LLOQ = Lower Limit of quantitation	After 12 weeks of the last dose	No
Secondary	Proportion of subjects with hemoglobin < 10g/dL		First 12 weeks of treatment	Yes
Secondary	Proportion of subjects with rash-related dermatologic events		First 12 weeks of treatment	Yes
Secondary	Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort	EOT = End of treatment	At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24	No
Secondary	Proportion of subjects with HCV RNA target not detected in the naive cohort	eRVR = Extended rapid virologic response	At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24	No
Secondary	Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort		At post-treatment Week 12	No
Secondary	Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort		At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24	No
Secondary	Proportion of subjects with HCV RNA target not detected in the relapser cohort		At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24	No
Secondary	On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group		End of treatment (24 weeks) plus 7days	Yes

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