deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT01856634

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions Multidrug Resistant Tuberculosis Pediatric
Interventions 10 mg Delamanid Pediatric Formulation 100 mg Delamanid 25 mg Pediatric Formulation Delamanid 5 mg Delamanid Pediatric Formulation 50 mg Delamanid Optimized Background Regimen
Updated 8 times since 2017 Last updated: Jan 27, 2018 Started: Jun 14, 2013 Primary completion: Dec 10, 2017 Completion: Dec 28, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Multidrug Resistant Tuberculosis and Pediatric and is currently completed. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 8 recorded versions since 2013 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshotRecruiting~Apr 2017 – ~Feb 2018 · 10 months · monthly snapshotRecruiting~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE1

    Status: Recruiting → Completed

▶ Show 3 earlier versions

  1. Apr 2017 — Feb 2018 [monthly]

    Recruiting PHASE1

  2. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Jun 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Otsuka Pharmaceutical Development & Commercialization, Inc.
Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations