Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Leprosy, Multibacillary
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.
Eligibility Criteria
Inclusion
- Participant has: a) multibacillary (MB) leprosy, defined as 6 or more skin lesions or extensive confluent lesions or diffuse skin involvement, and is either borderline lepromatous or polar lepromatous, as determined using Ridley and Jopling classification system; and b) has a bacteriological index of \>=4+ from the lesion biopsy obtained at screening, and a bacteriological index of \>= 1+ from each of 4 slit skin smear assessments taken at screening
- Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- a man must agree not to donate sperm throughout treatment with TMC207 and for 3 months after treatment is stopped
- Willing and able to adhere to the prohibitions, restrictions, and long-term follow up requirements specified in this protocol
- If a woman is of childbearing potential, must be practising a highly effective method of birth control (failure rate of \<1% per year when used consistently and correctly) before entry, and must also agree to use a barrier contraceptive method (that is, male or female condom, diaphragm or cervical cap) plus spermicide. participant must also agree to continue to use a highly effective method of contraception plus a barrier method throughout treatment with TMC207 and until 6 months after treatment is stopped
Exclusion
- Has experienced or is experiencing a lepra reaction requiring treatment with a prohibited therapy
- Has a contraindication limiting the implementation of a medically accepted MB leprosy regimen
- a) Has ever received pharmacotherapy for leprosy; b) has ever been treated with a drug that is a component of the primary World Health Organization (WHO) regimen for the treatment of MB leprosy (example, dapsone, rifampicin, clofazimine). Short-term (\<=2 weeks) pharmacotherapy with any antibiotic that could be used as a second line treatment for leprosy (eg, of the macrolide, quinolone, or tetracycline class) is acceptable as long as the last administration occurred \>=4 weeks before first dose of study drug (TMC207)
- Has a concomitant infection that requires an additional systemic antimicrobial agent
- Has tuberculosis (TB), as determined by medical history and chest x-ray
- Is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03384641
Start Date
September 26 2018
End Date
January 9 2024
Last Update
February 2 2024
Active Locations (2)
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1
Instituto Lauro de Souza Lima
Bauru, Brazil, 17034-971
2
Fundacao Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta - FUHAM
Manaus, Brazil, 69065-130