Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapy

• Conditions: Chronic Hepatitis C Virus Infection (Genotype 1b); MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005409-65-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-18
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 585

Inclusion Criteria

• Patients chronically infected with HCV GT-1b
• Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks)
• HCV RNA viral load = 100,000 IU/mL at screening
• Patients with compensated cirrhosis are permitted

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 527
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

• Infection with HCV other than GT-1b
• Positive HBsAg or 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
• Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
• Laboratory values: hemoglobin < 12.0 g/dL (males) or < 11.0 g/dL (females), platelets <90,000/mm³, total serum bilirubin = 2 mg/dL (unless due to Gilbert’s disease)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified