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-DE
• 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: 28 September 2015

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, to be determined based upon local guidelines)
• 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