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

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222495

Enrollment

286

Registered

2014-05-26

Start date

2014-05-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus Infection

Interventions

investigational material(s) Generic name etc : DCV 3DAA:Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination INN of investigational material : Therapeutic category code : 62

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females, at least 20 years of age Subjects chronically infected with HCV GT-1 HCV RNA viral load of not less than 100,000 IU/mL

Exclusion criteria

Exclusion criteria: Hepatocellular carcinoma Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) Severe or uncontrollable complication

Design outcomes

Primary

Measure	Time frame
Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA less than LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12 [ Time Frame: After 12 weeks of the last dose ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325 [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects who achieve HCV RNA less than 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) [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects who achieve HCV RNA less than 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 [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] 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 [ Time Frame: Approximately 48 weeks ] [ Designated as safety issue: Yes ] based on the US National Institutes of Health Division of AIDs (DAIDS) criteria The proportion of subjects with anemia defined as Hb less than 10 g/dL on-treatment who had Hb not less than 10 g/dL at baseline [ Time Frame: Approximately 48 weeks ] [ Designated as safety issue: Yes ] The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects in each cohort who	—

Measure

Time frame

The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325 [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects who achieve HCV RNA less than 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) [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects who achieve HCV RNA less than 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 [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] 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 [ Time Frame: Approximately 48 weeks ] [ Designated as safety issue: Yes ] based on the US National Institutes of Health Division of AIDs (DAIDS) criteria The proportion of subjects with anemia defined as Hb less than 10 g/dL on-treatment who had Hb not less than 10 g/dL at baseline [ Time Frame: Approximately 48 weeks ] [ Designated as safety issue: Yes ] The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b [ Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ] The proportion of subjects in each cohort who

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026