Completed PHASE2 INTERVENTIONAL 5-arm NCT01215110

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)

A Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of TMC207 in Adult Patients With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis.

Sponsor: Global Alliance for TB Drug Development

Conditions Pulmonary Tuberculosis

Interventions Rifafour e-275 mg TMC207

Updated 9 times since 2017 Last updated: Mar 15, 2017 Started: Apr 30, 2010 Primary completion: Aug 31, 2010 Completion: Sep 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01215110, this PHASE2 trial focuses on Pulmonary Tuberculosis and remains completed. Sponsored by Global Alliance for TB Drug Development, it has been updated 9 times since 2010, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2023 — Jul 2024 [monthly]

Completed PHASE2
Dec 2022 — Jan 2023 [monthly]

Completed PHASE2
Jan 2021 — Dec 2022 [monthly]

Completed PHASE2

▶ Show 4 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Jun 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Jun 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Apr 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Global Alliance for TB Drug Development

Data source: Global Alliance for TB Drug Development

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Belville, South Africa