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A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

NCT00812331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-07-28

Study results available
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Summary

The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.

Conditions

  • Hepatitis C

Interventions

DRUG

TMC435

From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals, Ireland Clinical Trial · Tibotec Pharmaceuticals, Ireland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Belgium
  • Germany
  • Thailand

Study Locations

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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 NCT00812331 on ClinicalTrials.gov