Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Par… (NCT05221502) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
South Africa122 participantsStarted 2022-04-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Male or female participants between 18 and 65 years of age (inclusive) at the screening visit.
✓. Body weight ≥ 35.0 kg at the screening visit.
✓. Newly diagnosed, rifampin and isoniazid susceptible (on the screening sample) pulmonary TB.
✓. Able to spontaneously produce sputum.
✓. 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.
✓. 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
✕. 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.
✕. Evidence of clinically significant metabolic (for example, including ongoing or current hypokalemia \[ie, potassium \<3.5 mEq/dL at screening\]), gastrointestinal, neurological, psychiatric, endocrine or liver (eg, hepatitis B and C) disease; malignancy; or other abnormalities (other than the indication being studied).
What they're measuring
1
Incidence of Treatment Emergent Adverse Events
Timeframe: Baseline to 12 months post randomization
2
Incidence of potentially clinically significant changes of laboratory tests from baseline and abnormalities in the vital signs, physical examinations, electrocardiograms (ECGs) at each visit were assessed and at end of study.
Timeframe: Baseline to 12 months post randomization
3
Number of participants with a grade 3 or higher AE
Timeframe: Baseline to 12 months post randomization
4
Number of all cause Treatment Discontinuation
Timeframe: Baseline to 12 months post randomization
5
Sputum culture conversion (SCC) in Mycobacteria Growth Indicator Tube® (MGIT)
Timeframe: Baseline to End of Treatment Period - Week 17 and Week 26
Trial details
NCT IDNCT05221502
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. History of, or current, clinically relevant cardiovascular disorder such as heart failure, coronary heart disease, uncontrolled hypertension, arrhythmia or symptom strongly suggestive of such a problem (for example, syncope or palpitations), tachyarrhythmia or status after myocardial infarction.
✕. Known bleeding disorders or family history of bleeding disorders.
✕. Any diseases or conditions in which the use of DLM, BDQ, OPC 167832, rifampin, isoniazid, pyrazinamide, or ethambutol is contraindicated.
✕. Any prior treatment for M tuberculosis within the past 2 years.
✕. Any treatment with a drug active against M tuberculosis (eg, quinolones) within the 3 months prior to screening.
✕. Clinical evidence of severe extrapulmonary TB (eg, miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).