A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibac… (NCT03384641) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
Brazil11 participantsStarted 2018-09-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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…
What they're measuring
1
Change from Baseline in the Odds of Mycobacterium leprae (M. leprae) Growth in Mouse Footpads Following 8 Weeks of Treatment with Bedaquiline