Trial

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

Study Director
Jeffrey Hafkin
Start Date
/ 2022
Trial Phase
Trial Status
study in development
Current Enrollment
Target Enrollment
120
Overview

Arm 1: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg thrice-weekly [TIW]) + OPC-167832 (10 mg QD) for 17 weeks

Arm 2: DLM (300 mg QD) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks

Arm 3: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks

Arm 4: RHEZ for 8 weeks followed by 18 weeks of rifampin and isoniazid (for a total of 26 weeks)

Randomization will be stratified by HIV status (yes or no) and presence of bilateral cavitation on screening chest x-ray (yes or no). After the end of the treatment period, subjects will be followed until 12 months postrandomization.

Seven sites in South Africa.