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Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

NCT01728324 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2016-02-12

Study results available
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Summary

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI 207127-placebo: 8-week treatment

8 weeks of placebo treatment

DRUG

Ribavirin: 24-week treatment

24 weeks of active treatment

DRUG

BI 207127: 24-week treatment

24 weeks of active treatment

DRUG

Faldaprevir: 24-week treatment

24 weeks of active treatment

DRUG

Faldaprevir: 24-week treatment

24 weeks of active treatment

DRUG

Ribavirin-placebo: 8-week treatment

8 weeks of placebo treatment

DRUG

BI 207127: 24-week treatment

24 weeks of active treatment

DRUG

Faldaprevir-placebo: 8-week treatment

8 weeks of placebo treatment

DRUG

Faldaprevir: 16-week treatment

16 weeks of active treatment

DRUG

Ribavirin: 16-week treatment

16 weeks of active treatment

DRUG

RBV: 24-week treatment

24 weeks of active treatment

DRUG

BI 207127: 16-week treatment

16 weeks of active treatment

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-02-28
Completion
2015-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • New Zealand
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01728324 on ClinicalTrials.gov