The purpose of this study is to provide safety and efficacy data for TMC207 and to
demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the
BR plus placebo.
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
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01600963
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within the preceding 3 weeks) at screening and also on Day -1
Has known infection with extensively drug resistant tuberculosis isolate
Has a clinically significant active medical condition such as, but not limited to, hepatic, pancreatic, renal, cardiovascular, gastrointestinal, hematologic, neurologic, locomotor, immunologic, ophthalmologic (e.g., corneal opacification or ulcers, uveitis, chorioretinitis), metabolic (except stable diabetes based on the investigator's judgement), endocrine, oncological disease, muscular disease (e.g., myositis, rhabdomyolysis), or psychiatric, dermatological illness, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results. Eligibility of patients with poorly controlled diabetes as indicated by hemoglobin A1c higher than the normal range at screening should be based on the investigators judgment
All locations for NCT01600963
Porto Alegre, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
Phnom Penh, Cambodia
Addis Ababa, Ethiopia
Korea, Republic of (6)
Busan, Korea, Republic of
Daegu, Korea, Republic of
Gwangju, Korea, Republic of
Gyeongsangnam-Do, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Stopinu Region, Latvia
Quezon City, Philippines
Russian Federation (6)
Arkhangelsk, Russian Federation
Ekaterinburg, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
Orel, Russian Federation
Saint-Petersburg, Russian Federation
South Africa (3)
Paarl, South Africa
Sandringham, South Africa
Ysterplaat, South Africa
Changhua County, Taiwan
New Taipei City, Taiwan
AURORA Investigative Center
View full eligibility
Tris trial is registered with FDA with number: NCT01600963. The sponsor of the trial is Janssen Infectious Diseases BVBA and it is looking for 0 volunteers for the current phase.
Official trial title: A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)
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