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

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: DCV 3DAA; Drug: Daclatasvir; Drug: Asunaprevir; Other: Placebo for Daclatasvir; Other: Placebo for Asunaprevir; Other: Placebo for DCV 3DAA

• Registration Number: NCT02123654
• Lead Sponsor: Bristol-Myers Squibb

Brief 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).

Detailed Description

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Primary Completion: 2015-01
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV	DCV 3DAA	DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Arm 2: DCV/ASV + Placebo for DCV 3DAA	Asunaprevir	Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Arm 2: DCV/ASV + Placebo for DCV 3DAA	Daclatasvir	Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV	Placebo for Daclatasvir	DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV	Placebo for Asunaprevir	DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Arm 2: DCV/ASV + Placebo for DCV 3DAA	Placebo for DCV 3DAA	Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
DCV 3DAA	DCV 3DAA	DCV 3DAA (open label) Tablet orally twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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	Approximately 48 weeks	based on the US National Institutes of Health Division of AIDs (DAIDS) criteria
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
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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Saga, Japan