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IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

NCT01732796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2016-04-18

Study results available
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Summary

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Ribavirin (RBV)

24 weeks of active RBV

DRUG

BI 201335 (Faldaprevir)

16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

DRUG

Ribavirin (RBV)

24 weeks of active RBV

DRUG

BI 207127

24 weeks of BI 207127

DRUG

BI 201335 (Faldaprevir)

24 weeks of BI 201335

DRUG

Ribavirin (RBV)

16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin

DRUG

BI 207127

16 weeks BI 207127 followed by 8 weeks placebo to BI 207127

DRUG

Faldaprevir (BI 201335)

24 weeks of 201335

DRUG

BI 207127

24 weeks of BI 207127

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
2012-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • Romania
  • Russia
  • 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 NCT01732796 on ClinicalTrials.gov