Status:
APPROVED_FOR_MARKETING
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
Lead Sponsor:
Janssen Infectious Diseases BVBA
Conditions:
Tuberculosis
Eligibility:
All Genders
18-99 years
Brief Summary
The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to isoniazid (INH),...
Detailed Description
TMC207 is being investigated for the treatment of TB. TB is a contagious bacterial infection caused by M. tuberculosis that commonly affects the lungs, but can also affect other organs. Treatment of T...
Eligibility Criteria
Inclusion
- Confirmed pulmonary XDR or pre-XDR-TB infection with resistance to INH, RMP, and to a FQ and/or injectable second line TB drug (kanamycin, amikacin, or capreomycin). Confirmation should include previous (within the preceding 6 months) smear or culture and drug susceptibility testing (DST) results demonstrating pulmonary TB with an XDR or pre-XDR resistance pattern
- Patient has limited or no treatment options and is unable/ineligible to participate in any other TMC207 study
- Patient will be managed at a medical center that has been certified by the Green Light Committee of the World Health Organization (WHO) Stop TB Partnership, OR, following an assessment of the site confirms that the site meets equivalent standards. Patients must be able to receive at least 3 anti-TB drugs to which the patient's infection is known to be susceptible from recent DST results (within the previous 6 months) or likely to be susceptible, based on known treatment history, per availability in the country
- Patient is medically stable in the opinion of the investigator on the basis of physical examination, and safety examinations performed at screening
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the early access study
Exclusion
- History of and/or clinically relevant, currently active or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, respiratory (other than due to TB), inflammatory, neoplastic, skin, immunological or infectious disease, which is not stable and controlled. If there are clinically relevant, currently active or underlying diseases, they should not compromise the safety of the patient or the ability to participate in the study as judged by the investigator. The investigator is encouraged to discuss concomitant illnesses with the sponsor
- Patients with complicated or severe extra-pulmonary manifestations of TB, including osteoarticular and central nervous system infection - Patients having received TMC207 in a previous study
- Any condition that, in the opinion of the investigator, would compromise the early access study or the well-being of the patient or prevent the patient from meeting or performing protocol requirements
- Current alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise patient's safety and/or compliance with the protocol procedures
- Patients with any clinically significant electrocardiogram abnormality at screening
- Patients having received medications (within the last 7 days prior to Day 1) that have the potential of prolonging the QT interval
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01464762
Last Update
November 27 2017
Active Locations (5)
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1
Vilnius, Lithuania
2
Arkhangelsk, Russia
3
Moscow, Russia
4
Oryol, Russia