Safety and Efficacy Study of Peginterferon Lambda-1a With and Without Daclatasvir, Compared to Peginterferon Alfa-2, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naive Genotype 2 and 3 Chronic Hepatitis C Subjects

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221960

Enrollment

875

Registered

2012-11-12

Start date

2012-11-12

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

Chronic HCV GT-2 and -3

Interventions

investigational material(s) Generic name etc : Lambda/RBV/Placebo INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Compensated cirrhotic and non-cirrhotic subjects who are naive to prior anti-HCV therapy, and have chronic HCV GT-2 or- 3 infection with HCV RNA viral load greater than or equal to 100,000 IU/mL. For Japan, compensated and non-compensated cirrhotics will NOT be included in this study.

Exclusion criteria

Exclusion criteria: Infected with HCV other than Genotype 2 or 3. Evidence of medical condition associated with chronic liver disease other than HCV. Positive HBsAg, or HIV-2/HIV-2 antibody at screening. Active substance abuse (eg, alcohol, inhaled/injected drugs) within 6 months prior to screening. Use of hematologic growth factors within 90 days prior to randomization. Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria.

Design outcomes

Primary

Measure	Time frame
SVR12 HCV RNA < 25 IU/mL (detected or not detected) at Week 12 of post-treatment follow-up	—

Secondary

Measure	Time frame
- RVR - Treatment emergent cytopenic abnormalities - Interferon-associated flu-like symptoms - On-treatment musculoskeletal symptoms - SVR24 - On-treatment SAEs - Dose reductions through end of treatment - Discontinue due to AEs through end of treatment - SVR12 in subjects with GT-3 chronic HCV infection - On-treatment constitutional symptoms - RVR: undetectable HCV RNA at on-treatment Week 4 - Cytopenic abnormalities: Anemia, neutropenia or thrombocytopenia - Flu-like symptoms: Pyrexia or Chills or Pain - Musculoskeletal symptoms: Arthralgia or Myalgia or Back pain - SVR24: HCV RNA < 25 IU/mL (detected or not detected) at Week 24 of post-treatment follow-up - Constitutional symptoms: Fatigue or Asthenia	—

Measure

Time frame

- RVR - Treatment emergent cytopenic abnormalities - Interferon-associated flu-like symptoms - On-treatment musculoskeletal symptoms - SVR24 - On-treatment SAEs - Dose reductions through end of treatment - Discontinue due to AEs through end of treatment - SVR12 in subjects with GT-3 chronic HCV infection - On-treatment constitutional symptoms - RVR: undetectable HCV RNA at on-treatment Week 4 - Cytopenic abnormalities: Anemia, neutropenia or thrombocytopenia - Flu-like symptoms: Pyrexia or Chills or Pain - Musculoskeletal symptoms: Arthralgia or Myalgia or Back pain - SVR24: HCV RNA < 25 IU/mL (detected or not detected) at Week 24 of post-treatment follow-up - Constitutional symptoms: Fatigue or Asthenia

—

Outcome results

None listed

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