Pediatric Clinical Trial
Official title:
Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
This trial will investigate the pharmacokinetics (PK) and safety of delamanid administered
for 10 days to pediatric patients aged birth to 17 years who are also on therapy with an
optimized background regimen. The purpose of the trial is to determine which dose in
pediatric MDR-TB patients will result in delamanid plasma exposure similar to efficacious
plasma exposure in adult MDR-TB patients. This is an age de-escalation trial in four groups:
Group 1: 12 to 17 years (100 mg BID; n=6) Group 2: 6 to 11 years (50 mg BID; n=6) Group 3: 3
to 5 years (25 mg BID; n=12) Group 4: Birth to 2 years (Dose based on patient's body weight,
n=12)
- Patients > 10 kg will receive 10 mg BID
- Patients > 8 kg and ≤ 10 kg will receive 5 mg BID
- Patient ≤ to 8 kg will receive 5 mg QD
;
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