Status:
COMPLETED
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.
Lead Sponsor:
Janssen Infectious Diseases BVBA
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-...
Detailed Description
This is a Phase II, open-label (all people involved know the identity of the intervention) trial to evaluate the safety, tolerability, and efficacy of TMC207 as part of an individualized Multi-drug Re...
Eligibility Criteria
Inclusion
- Females of child-bearing potential must be using and are willing to continue using effective birth control methods, or be willing to practice sexual abstinence throughout treatment or be nonheterosexual active
- Confirmed pulmonary MDR-TB infection including those infected with XDR (extensively drug resistant)-TB
- Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (= 1+ smear-positive)
- HIV-positive patients are eligible, provided they meet the requirements as described in the protocol
- Must voluntarily sign the Informed Consent Form (ICF) prior to starting any study activities
- Willing to comply with protocol requirements
- Willing to comply with NTP treatment guidelines
Exclusion
- Patients having a known or suspected hypersensitivity or serious adverse reaction to TMC207
- Patients with significant cardiac arrhythmia requiring medication
- Patients with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection
- Patients with certain QT/QTc interval characteristics as described in the protocol
- Patients having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start
- Women who are pregnant or breastfeeding
- Patients who have previously received treatment with TMC207 as part of a clinical trial.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00910871
Start Date
September 1 2009
End Date
January 1 2013
Last Update
April 24 2015
Active Locations (27)
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1
Beijing, China
2
Fuzhou, China
3
Jinan, China
4
Nanjing, China