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

NCT01600963 | Withdrawn Phase 3 DMC

• 4 other identifiers: CR100807TMC207-TIDP13-C2102011-000653-23U1111-1135-7013
• Study Type: interventional
• Target: N/A
• Locations: 17 countries
• Sites: 44

Brief Summary

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.

Conditions

Multi-drug Resistant Tuberculosis

Keywords

Multi-drug resistant tuberculosis; Pre-extensively drug resistant tuberculosis; TMC207; Background regimen

Outcome Measures

Primary Outcomes (1)

• Number of patients with favorable treatment outcome at Week 60

  Week 60

Secondary Outcomes (27)

• Number of patients with confirmed culture conversion at Week 84

  Week 84

• Number of patients with confirmed culture conversion at Week 60 or at time of trial discontinuation

  Up to Week 132

• The number of patients with development of pre-extensively drug-resistant tuberculosis and extensively drug-resistant tuberculosis

  Up to Week 132

• Time to sputum culture conversion

  Up to Week 132

• Number of patients with negative culture and smear for tuberculosis

  Up to Week 132

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Arm A Double-blind Phase: TMC207; Drug: Treatment Failure During Double-blind Phase: TMC207; Drug: Treatment Failure During Follow-up Phase: TMC207

Arm B

PLACEBO COMPARATOR

Drug: Arm B Double-blind Phase: Placebo; Drug: Treatment Failure During Double-blind Phase: TMC207; Drug: Treatment Failure During Follow-up Phase: TMC207

Interventions

Arm A Double-blind Phase: TMC207 DRUG

Type=exact number, unit=mg, number=400 mg for the first 2 weeks and 200 mg 3 times per week for the remainder of the treatment period, form=tablet, route=oral administration.

Arm A

Arm B Double-blind Phase: Placebo DRUG

Form=tablet, route=oral administration, taken once daily for 2 weeks then 3 times per week for the remainder of the treatment period.

Arm B

Treatment Failure During Double-blind Phase: TMC207 DRUG

Type=exact number, unit=mg, number=200 mg 3 times per week, form=tablet, route=oral administration.

Arm A; Arm B

Treatment Failure During Follow-up Phase: TMC207 DRUG

Type=exact number, unit=mg, number=400 mg once daily for 2 wks and 200mg three times per week for 22 weeks, form=tablet, route=oral administration.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Infectious Diseases BVBA: lead

Study Sites (44)

Unknown Facility

Porto Alegre, Brazil

Location

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Rio de Janeiro, Brazil

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São Paulo, Brazil

Location

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Phnom Penh, Cambodia

Location

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Beijing, China

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Changsha, China

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Chongqing, China

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Fuzhou, China

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Jinan, China

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Nanjing, China

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Shanghai, China

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Kohtla-Järve, Estonia

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Talinn, Estonia

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Addis Ababa, Ethiopia

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Gonder, Ethiopia

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Tbilisi, Georgia

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Stopinu Region, Latvia

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Monterrey, Mexico

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Lima, Peru

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Quezon City, Philippines

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Arkhangelsk, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Oryol, Russia

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Saint Petersburg, Russia

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Yekaterinburg, Russia

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Paarl, South Africa

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Sandringham, South Africa

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Ysterplaat, South Africa

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Busan, South Korea

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Daegu, South Korea

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Gwangju, South Korea

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Gyeongsangnam-Do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Changhua County, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Nonthaburi, Thailand

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Keçiören, Turkey (Türkiye)

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Donetsk, Ukraine

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Kiev, Ukraine

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Ternopil, Ukraine

Location

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Janssen Infectious Diseases BVBA Clinical Trial

  Janssen Infectious Diseases BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: May 17, 2012
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2022
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

KR (6); TU (1); GE (1); CA (1); CN (7); TH (1); ME (1); LA (1); PH (1); TW (4); ES (2); BR (3); ET (2); PE (1); UA (3); RU (6); ZA (3)