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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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 naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

NCT01718158•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients chronically infected with HCV Genotype-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

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
•Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
•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 (unless due to Gilbert's disease)

Locations (78)

Va Long Beach Healthcare System

Long Beach, California, United States

Gastrointestinal Specialists Of Georgia Pc

Marietta, Georgia, United States

Weill Cornell Medical College

New York, New York, United States

Premier Medical Group Of The Hudson Valley, Pc

Poughkeepsie, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

Texas Clinical Research Institute, Llc

Arlington, Texas, United States

Medvamc

Houston, Texas, United States

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Key Dates

Start Date

January 1, 2013

Primary Completion Date

October 1, 2014

Completion Date

October 1, 2014

Last Updated

October 9, 2015

Enrollment

444

ACTUAL participants

Conditions

Hepatitis C

Interventions

Peginterferon Lambda-1a

BIOLOGICAL

Peginterferon Alfa-2a

BIOLOGICAL

Ribavirin

DRUG

Daclatasvir

DRUG

Telaprevir

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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