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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

NCT01358864 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2016-08-29

Study results available
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Summary

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI 201335

BI 201335 once a day (QD) for 24 weeks

DRUG

Pegylated Interferon-alpha (IFN)

Pegylated Interferon-alpha for 48 weeks

DRUG

Ribavirin (RBV)

Ribavirin (RBV) for 24 or 48 weeks

DRUG

Placebo

Placebo to BI201335 for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2014-05-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Japan
  • Portugal
  • Puerto Rico
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358864 on ClinicalTrials.gov