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

> **NCT01600963** · PHASE3 · WITHDRAWN · sponsor: **Janssen Infectious Diseases BVBA**

## Conditions studied

- Multi-drug Resistant Tuberculosis

## Interventions

- **DRUG:** Arm A Double-blind Phase: TMC207
- **DRUG:** Arm B Double-blind Phase: Placebo
- **DRUG:** Treatment Failure During Double-blind Phase: TMC207
- **DRUG:** Treatment Failure During Follow-up Phase: TMC207

## Key facts

- **NCT ID:** NCT01600963
- **Lead sponsor:** Janssen Infectious Diseases BVBA
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2014-03
- **Primary completion:** 2016-07
- **Final completion:** 2022-11
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** PhIII program revised; TMC207-C210 cancelled
- **Last updated:** 2015-12-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01600963

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01600963, "A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01600963. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
