A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy versus Telaprevir Therapy in Japanese HCV subjects.

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221958

Enrollment

224

Registered

2012-11-19

Start date

2012-11-19

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 : Daclatasvir + Asunaprevir (Naive cohort) INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - chronic HCV-1b infected patient - HCV 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 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

Exclusion criteria: Patients who have; - hepatocellular carcinoma - co-infection with HBV or HIV - severe or uncontrollable complication

Design outcomes

Primary

Measure	Time frame
To assess proportion of SVR12 (below LLOQ) at post treatment week12 in naive cohort	—

Secondary

Measure	Time frame
- To compare proportion of hemoglobin decreased - To compare the proportion of rash related event. - To assess anti-viral activity in naive cohort - To assess anti-viral activity in relapser cohort - To assess safety	—

Outcome results

None listed

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