EUCTR2021-006613-10-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Multicenter, Open-label, Rater-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline for the Treatment of Multibacillary Leprosy When Combined With Rifampicin and Clofazimine - LIGHT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. Fifteen years and older, on the day of signing the ICF/assent.
- •2. Has presence of acid-fast bacilli in any slit-skin smear taken at screening from a skin lesion from which a biopsy can be taken.
- •3. Has at least 3 skin lesions, consistent with MB leprosy, of which 2 measure at least 5 cm in diameter.
- •OR at least 10 nodules/lepromas, consistent with MB leprosy, of which 2 measure at least 0.5 cm in diameter.
- •OR at least 1 confluent skin lesion, consistent with MB leprosy, which measures at least 8 cm in diameter.
- •4. Human immunodeficiency virus-infected participants are allowed if the participant:
- •a. Has a documented HIV-positive status prior to screening.
- •b. Started antiretroviral therapy at least 12 weeks before baseline.
- •c. Is on, or switches to, an ART regimen not containing efavirenz at least 4 weeks prior to enrollment.
- •d. Has a CD4+ cell count =200 cells/µL.
- •e. Has no acquired immunodeficiency syndrome (AIDS)-defining illness or did not show severe symptoms of HIV infection that would make the participant a poor candidate for participation in the study.
- •5. Has a body weight =30 kg
- •6. A female participant of childbearing potential must have a negative highly sensitive pregnancy test at screening and on Day 1 before
- •randomization.
- •7. A female participant must be
- •a. Not of childbearing potential
- •b. Of childbearing potential and adhering to the recommendations as specified in the protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 19
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 199
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1. Has the clinical characteristics of leprosy but presenting only with diffuse infiltration without specific lesions, or with only hypochromic/hypopigmented macules.
- •2. Has active tuberculosis, ongoing leishmaniasis or Chagas disease, or active hepatitis B or hepatitis C.
- •3. Has a history of or current non-leprosy-related neuropathies that would affect the interpretation of data collected in the nerve function clinical testing.
- •4. Has any skin disorder that, in the opinion of the investigator, might interfere with the assessment of leprosy skin lesions.
- •5. Has a relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism, or excretion such as malabsorption syndrome or renal or hepatic disease.
- •6. Has any of the following cardiac risk factors during the screening period:
- •- Clinical signs of heart failure.
- •- QTcF interval >450 ms (confirmed by repeat ECG).
- •- A personal or family history of congenital QT interval prolongation (long QT syndrome).
- •- A history of or ongoing inadequately treated or untreated hypothyroidism.
- •- A history of or ongoing bradyarrhythmia (HR <50 bpm).
- •- A history of Torsade de Pointes.
研究者
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