Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449644
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2007-03-16
Brief Title:
TMC207-TiDP13-C208 Anti-bacterial Activity Safety and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis MDR-TB
Sponsor:
Janssen Infectious Diseases BVBA
Organization:
Janssen Infectious Diseases BVBA
Study Overview
Official Title:
A Phase II Placebo-controlled Double-blind Randomized Trial to Evaluate the Anti-bacterial Activity Safety and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis MDR-TB
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The trial will be conducted in 2 consecutive stages an exploratory investigative stage Stage 1 and a proof of effectiveness stage Stage 2 During Stage 1 a panel of 50 participants will be randomized participants are assigned different treatments based on chance to receive either TMC207 or placebo for 8 weeks on top of a BR In Stage 2 another panel of 150 participants will be randomized to receive either TMC207 or placebo for 24 weeks on top of a BR TMC207 will be dosed as 400 mg every day for the first 2 weeks and as 200 mg 3 timesweek for the following 6 or 22 weeks during Stages 1 and 2 respectively When the participants in Stage 1 have completed 8 weeks double-blind neither theparticipant nor the physician knows whether drug or placebo is being taken or at what dosage treatment with TMC207 or placebo or have discontinued earlier the primary Stage 1 analysis will be performed on all data of the first 8 weeks of treatment Following this Stage 1 analysis Stage 2 will be initiated and a panel of 150 new participants will be enrolled After the double-blind treatment phase in both Stage 1 and Stage 2 participants will continue to receive MDR-TB treatment as per national treatment guidelines They will be followed for safety tolerability pharmacokinetics and microbiological efficacy for 96 weeks after receiving their last dose of TMC207 or placebo The Data Safety Monitoring Board Committee will review these data on a regular basis The DSMBDSMC is a group of experts in tuberculosis and clinical trial conduct who have no commercial interests in the development of TMC207 and the company Tibotec BVBA that is developing the new TB drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-004462-40 | EUDRACT_NUMBER | Janssen Infectious Diseases BVBA | None |
| TMC207-TIDP13-C208 | OTHER | None | None |