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4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

NCT00905632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-04-19

Study results available
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Summary

The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI 207127 middle dose +SOC

BI 207127 middle dose tid + SOC

DRUG

BI 207127 high dose+SOC

BI 207127 high dose tid +SOC

DRUG

Placebo + SOC

Placebo tid +SOC

DRUG

BI 207127 low dose + SOC

BI 207127 low dose tid + SOC

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
2009-05-31
Primary Completion
2011-03-31

Countries

  • France
  • Germany
  • Switzerland

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 NCT00905632 on ClinicalTrials.gov