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COMPLETED
NCT05221502
PHASE2

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 26 weeks.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2022-04-12

Completion Date

2024-05-19

Last Updated

2026-07-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Delamanid

Delamanid (300 mg QD) for 17 weeks

DRUG

Bedaquiline

Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) for 17 weeks

DRUG

RHEZ

RHEZ (RIFAFOUR single dose combination tablets) for 8 weeks

DRUG

Rifampin

Rifampin tablets for 18 weeks

DRUG

Isoniazid

Isoniazid tablets for 18 weeks

DRUG

OPC-167832 10 mg

OPC-167832 (10 mg QD) for 17 weeks

DRUG

OPC-167832 30 mg

OPC-167832 (30 mg QD) for 17 weeks

DRUG

OPC-167832 90 mg

OPC-167832 (90 mg QD) for 17 weeks

Locations (6)

Aurum Institute - Tembisa Clinical Research Centre

Tembisa, Gauteng, South Africa

TASK Applied Science, Brooklyn Chest Hospital Premises

Cape Town, South Africa

University of CapeTown Lung Center Institute

Cape Town, South Africa

Themba Lethu Clinic Clinical HIV Research Unit (CHRU)

Johannesburg, South Africa

Perinatal HIV Research Unit Tshepong Hospital Complex

Klerksdorp, South Africa

Setshaba Research Center

Pretoria, South Africa