Phase 2 N=207 Randomized Triple-blind Treatment

TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).

Tuberculosis

Bottom Line

View on ClinicalTrials.gov: NCT00449644 ↗

Enrolled (actual)

207

Serious AEs

16.9%

Results posted

Jun 2013

Primary outcome: Primary: The Time to Sputum Culture Conversion at Week 8 (Stage 1) — 51; NA Days — p=0.0034

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TMC207 (Drug); Placebo (Drug); Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Infectious Diseases BVBA
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Time to Sputum Culture Conversion at Week 8 (Stage 1)	51; NA	0.0034 sig
PRIMARY The Time to Sputum Culture Conversion at Week 24 (Stage 2)	83; 125	<0.0001 sig
SECONDARY The Time to Sputum Culture Conversion at Week 24 (Stage 1)	70; 126	0.0022 sig
SECONDARY The Time to Sputum Culture Conversion at Week 72 (Stage 2)	86; 168	0.0290 sig
SECONDARY The Percentage of Participants With Sputum Culture Conversion (Stage 1)	47.6; 8.7; 81.0; 65.2; 52.4; 43.5	0.003 sig
SECONDARY The Percentage of Participants With Sputum Culture Conversion (Stage 2)	78.8; 57.6; 71.2; 56.1; 62.1; 43.9	0.008 sig

Summary

The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated.

Eligibility Criteria

Inclusion Criteria

Females of non-childbearing potential
Patients with newly diagnosed sputum smear-positive pulmonary MDR-TB infection
Patients must consent to HIV-testing
Patients must be willing to discontinue all TB drugs to allow 7 days washout
Patients having normal weight
Patients are willing to be hospitalized per standard of care.

Exclusion Criteria

Previously having been treated for MDR-TB
Having a significant cardiac arrhythmia that requires medication
For HIV infected patients, having a CD4+ count < 300 cells/µL
Patients with complicated or severe extrapulmonary manifestations of TB or neurological manifestations of TB
Patients who will require surgical procedure for management of their TB
Evidence of chorioretinitis, optic neuritis, or uveitis at screening
Having had a drug susceptibility test performed prior to screening and being not susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB
Women who are pregnant and/or breastfeeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00449644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.