UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Hepatitis C Virus Infection Clinical Trial

Official title:

A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123654
• Other study ID #: AI443-117
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2014
• Last updated: September 16, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: August 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 demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Description:

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Males and females, = 20 years of age

• Subjects chronically infected with HCV GT-1

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

Exclusion Criteria:

• 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: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• Daclatasvir

• Asunaprevir

• DCV 3DAA

Other:
• Placebo for DCV 3DAA

• Placebo for Daclatasvir

• Placebo for Asunaprevir

Locations

Country	Name	City	State
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chuo-shi	Yamanashi
Japan	Local Institution	Fukui
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Gifu-shi	Gifu
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	Kashihara	Nara
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Kobe-shi	Hyogo
Japan	Local Institution	Kumamoto
Japan	Local Institution	Kurume-shi	Fukuoka
Japan	Local Institution	Kyoto-shi	Kyoto
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Miyazaki
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nishinomiya-shi
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Saga
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Suita	Osaka
Japan	Local Institution	Suita-shi	Osaka
Japan	Local Institution	Takamatsu-shi	Kagawa
Japan	Local Institution	Takasaki	Gunma
Japan	Local Institution	Yamagata-shi	Yamagata
Japan	Local Institution	Yokohama	Kanagawa

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 treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12		After 12 weeks of the last dose	No
Secondary	The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities	based on the US National Institutes of Health Division of AIDs (DAIDS) criteria	Approximately 48 weeks	Yes
Secondary	The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb = 10 g/dL at baseline		Approximately 48 weeks	Yes
Secondary	The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12		Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24	No
Secondary	On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria		Approximately 48 weeks	Yes

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