Trial Profile
Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC-67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs Over a 6-Month Treatment Period
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 14 Apr 2022
Price :
$35
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At a glance
- Drugs Delamanid (Primary) ; Antituberculars
- Indications Tuberculosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 11 Apr 2022 Results from phase 1 and phase 2 trials (NCT01856634 and NCT01859923) published in the Antimicrobial Agents and Chemotherapy
- 29 Nov 2021 Results (n=37) of population PK analysis to characterize the PK of delamanid in the pediatric population with data collected in Trials NCT01856634 and NCT01859923 and to calculate doses for pediatric participants across the entire age range, i.e between 0-17 years of age, that will result in systemic exposures of delamanid comparable to that of the approved dose in adults (100 mg BID), published in the Antimicrobial Agents and Chemotherapy.
- 26 Jul 2021 According to an Otsuka Pharmaceutical media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of Deltyba 25 mg dispersible tablets (delamanid) for use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.