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

NCT01343888 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2015-09-18

Study results available
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Summary

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Conditions

  • Hepatitis C

Interventions

DRUG

PegIFN/RBV

PegIFN/RBV for 48 weeks

DRUG

BI 201335

BI 201335 once daily high dose

DRUG

BI 201335

BI 201335 once daily low dose

DRUG

Placebo

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
2011-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Japan
  • Portugal
  • Romania
  • Russia
  • 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 NCT01343888 on ClinicalTrials.gov