← Back to all trials
Completed
NCT05221502
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
Conditions: Pulmonary TB
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 122
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Location: Aurum Institute - Tembisa Clinical Research Centre Tembisa Gauteng
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.
Eligibility Criteria
Inclusion Criteria:
1. Able to provide written, informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the investigator, to comply with all the requirements of the trial.
2. Male or female participants between 18 and 65 years of age (inclusive) at the screening visit.
3. Body weight ≥ 35.0 kg at the screening visit.
4. Newly diagnosed, rifampin and isoniazid susceptible (on the screening sample) pulmonary TB.
5. Able to spontaneously produce sputum.
6. Females of childbearing potential (FOCBP) must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or dose of RHEZ.
7. Male participants must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or RHEZ.
Exclusion Criteria:
1. Participants are known or suspected of having resistance to rifampin, isoniazid, ethambutol, pyrazinamide, DLM, or BDQ either confirmed by the laboratory, or based on epidemiological history, at screening.
2. Evidence of clinically significant metabolic (for example, including ongoing or current hypokalemia \[ie, potassium \
Source: ClinicalTrials.gov (NCT05221502). StuddyBuddy aggregates publicly available trial information.