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

NCT05221502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-04-10

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-04-08
Completion
2024-05-19
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221502 on ClinicalTrials.gov