A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naive or Prior Relapsers to Alfa/RBV Therapy

A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naive or Prior Relapsers to Alfa/RBV Therapy

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222042

Enrollment

450

Registered

2013-03-14

Start date

2013-03-14

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

Interventions

investigational material(s) Generic name etc : Peginterferon Lambda-1a + Ribavirin + Daclatasvir INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients chronically infected with HCV Genotype-1b Naive to prior treatment or documented evidence of relapse after 48 weeks of treatment with alfa/Ribavirin (RBV) HCV RNA viral load 100,000 copies/mL and more at screening

Exclusion criteria

Exclusion criteria: Infection with Hepatitis C virus (HCV) other than Genotype-1b Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening Evidence of chronic liver disease caused by diseases other than chronic HCV infection Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening Laboratory values: 1.Hemoglobin < 12.0 g/dL (males) or < 11.0 g/dL (females) 2.Platelets < 90,000/mm3 3.Total serum bilirubin 2 mg/dL and more (unless due to Gilbert's disease)

Design outcomes

Secondary

Measure	Time frame
Proportion of subjects who achieve SVR12 in treatment-naive subjects Proportion of subjects with rash related dermatologic events Treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3) Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ) at post-treatment follow-up Week 24) SVR24 = Sustained virologic response at post treatment follow-up Week 24	—

Measure

Time frame

Proportion of subjects who achieve SVR12 in treatment-naive subjects Proportion of subjects with rash related dermatologic events Treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3) Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ) at post-treatment follow-up Week 24) SVR24 = Sustained virologic response at post treatment follow-up Week 24

—

Primary

Measure	Time frame
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)	—

Outcome results

None listed

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