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To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.

NCT00910871 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2015-04-24

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB

Conditions

Interventions

DRUG

TMC207

TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks.

DRUG

Background Regimen (BR) for MDR-TB

Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks.

Sponsors & Collaborators

  • Janssen Infectious Diseases BVBA

    lead INDUSTRY

Principal Investigators

  • Janssen Infectious Diseases BVBA Clinical Trial · Janssen Infectious Diseases BVBA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-31
Completion
2013-01-31

Countries

  • China
  • Estonia
  • Kenya
  • Latvia
  • Peru
  • Philippines
  • Russia
  • South Africa
  • South Korea
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT00910871 on ClinicalTrials.gov