Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

April 12, 2022

Primary Completion Date

April 8, 2024

Study Completion Date

May 19, 2024

Conditions
Pulmonary TB
Interventions
DRUG

Delamanid + Bedaquiline + OPC-167832 10 mg

Delamanid (300 mg QD) + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (10 mg QD) for 17 weeks

DRUG

Delamanid + Bedaquiline + OPC-167832 30 mg

Delamanid (300 mg QD\] + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks

DRUG

Delamanid + Bedaquiline + OPC-167832 90 mg

Delamanid (300 mg QD) + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks

DRUG

RHEZ

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

Trial Locations (6)

1632

Aurum Institute - Tembisa Clinical Research Centre, Tembisa

2092

Themba Lethu Clinic Clinical HIV Research Unit (CHRU), Johannesburg

2574

Perinatal HIV Research Unit Tshepong Hospital Complex, Klerksdorp

7100

TASK Applied Science, Brooklyn Chest Hospital Premises, Cape Town

7700

University of CapeTown Lung Center Institute, Cape Town

0152

Setshaba Research Center, Pretoria

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY