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Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients

NCT01858961 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-01-23

No results posted yet for this study

Summary

The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI 201335

Once a day

DRUG

ribavirin

Twice a day

DRUG

BI 207127

Twice a day

DRUG

Telaprevir

Three times a day

DRUG

ribavirin

Twice a day

DRUG

Pegylated Interferon

Once a week

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Australia
  • Spain
  • Sweden

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 NCT01858961 on ClinicalTrials.gov