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Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

NCT00793793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-09-05

Study results available
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Summary

This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI201335

patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days

DRUG

BI201335

patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days

DRUG

BI201335

patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days

DRUG

BI201335

patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-01-31
Completion
2011-01-25

Countries

  • United States
  • France
  • Germany
  • Spain

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 NCT00793793 on ClinicalTrials.gov