WHO ICTRP trial
Efficacy and safety study of Bedaquiline in MB Leprosy.
CTRI/2025/02/079888 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2025/02/079888 |
|---|---|
| Public title | Efficacy and safety study of Bedaquiline in MB Leprosy. |
| Scientific title | 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 |
| Primary sponsor | Janssen Pharmaceutica NV |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Brazil;India |
| Conditions | Health Condition 1: A30- Leprosy [Hansens disease] |
| Interventions | Intervention1: Arm A: Bedaquiline-containing Multiple-drug Therapy (MDT): bedaquiline 200 mg qd for 14 days (intensive phase) followed by bedaquiline 800 mg q4w from Day 28 (5 intakes) in combination with RMP 600 mg q4w (6 intakes, starting… |
| Registration date | Mar 2, 2025 |
| Target size | 262 |
| Secondary IDs | 2021-006613-10;TMC207LEP3001, Version No. Original dated 09-NOV-2023 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: