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A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis

NCT01600963 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-12-02

No results posted yet for this study

Summary

The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.

Conditions

  • Multi-drug Resistant Tuberculosis

Interventions

DRUG

Arm A Double-blind Phase: TMC207

Type=exact number, unit=mg, number=400 mg for the first 2 weeks and 200 mg 3 times per week for the remainder of the treatment period, form=tablet, route=oral administration.

DRUG

Arm B Double-blind Phase: Placebo

Form=tablet, route=oral administration, taken once daily for 2 weeks then 3 times per week for the remainder of the treatment period.

DRUG

Treatment Failure During Double-blind Phase: TMC207

Type=exact number, unit=mg, number=200 mg 3 times per week, form=tablet, route=oral administration.

DRUG

Treatment Failure During Follow-up Phase: TMC207

Type=exact number, unit=mg, number=400 mg once daily for 2 wks and 200mg three times per week for 22 weeks, form=tablet, route=oral administration.

Sponsors & Collaborators

  • Janssen Infectious Diseases BVBA

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-07-31
Completion
2022-11-30

Countries

  • Brazil
  • Cambodia
  • China
  • Estonia
  • Ethiopia
  • Georgia
  • Latvia
  • Mexico
  • Peru
  • Philippines
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

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 NCT01600963 on ClinicalTrials.gov