Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
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ClinicalTrials.gov Identifier: NCT01464762 |
Expanded Access Status :
Approved for marketing
First Posted : November 4, 2011
Last Update Posted : November 27, 2017
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Condition or disease | Intervention/treatment |
---|---|
Tuberculosis | Drug: TMC207 |
Study Type : | Expanded Access |
Official Title: | Early Access of TMC207 in Combination With Other Anti-Tuberculosis (TB) Drugs in Subjects With Extensively Drug Resistant (XDR) or Pre-XDR Pulmonary Tuberculosis |

- Drug: TMC207
400mg once daily by mouth for 2 weeks followed by 200mg by mouth three times per week for 22 weeks + individualized background of antibacterial drugs

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464762
Lithuania | |
Vilnius, Lithuania | |
Russian Federation | |
Arkhangelsk, Russian Federation | |
Moscow, Russian Federation | |
Orel, Russian Federation | |
Saint-Petersburg, Russian Federation |
Study Director: | Janssen Infectious Diseases BVBA Clinical Trial | Janssen Infectious Diseases BVBA |
Responsible Party: | Janssen Infectious Diseases BVBA |
ClinicalTrials.gov Identifier: | NCT01464762 |
Other Study ID Numbers: |
CR017233 TMC207TBC3001 ( Other Identifier: Janssen Infectious Diseases BVBA ) 2010-021125-12 ( EudraCT Number ) |
First Posted: | November 4, 2011 Key Record Dates |
Last Update Posted: | November 27, 2017 |
Last Verified: | November 2017 |
Tuberculosis TMC207TBC3001 TMC207 Early access |
TB Drug resistant Multi drug-resistant Extensively drug-resistant |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Bedaquiline Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents |