deltatrials
Terminated PHASE1 INTERVENTIONAL 7-arm NCT01716234

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)

Sponsor: Merck Sharp & Dohme LLC

Conditions Fungal Infections
Interventions Posaconazole 12 mg/kg/day BID Posaconazole 12 mg/kg/day TID Posaconazole 18 mg/kg/day BID Posaconazole 18 mg/kg/day TID
Updated 13 times since 2017 Last updated: Jul 27, 2018 Started: Apr 17, 2008 Primary completion: Apr 1, 2015 Completion: Apr 1, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.

Other terminated trials from Merck Sharp & Dohme LLC

More terminations from Merck Sharp & Dohme LLC

This PHASE1 trial investigates Fungal Infections and is currently terminated or withdrawn. Merck Sharp & Dohme LLC leads this study, which shows 13 recorded versions since 2008 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Nov 2020 · 26 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Jun 2022 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Dec 2021 — Jun 2022 [monthly]

    Terminated PHASE1

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1

▶ Show 8 earlier versions

  1. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE1

  2. Sep 2018 — Nov 2020 [monthly]

    Terminated PHASE1

  3. Jun 2018 — Sep 2018 [monthly]

    Terminated PHASE1

  4. May 2018 — Jun 2018 [monthly]

    Terminated PHASE1

  5. Aug 2017 — May 2018 [monthly]

    Terminated PHASE1

  6. Jul 2017 — Aug 2017 [monthly]

    Terminated PHASE1

    Status: Completed → Terminated

  7. Feb 2017 — Jul 2017 [monthly]

    Completed PHASE1

  8. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Apr 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

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

Study Locations

No location information available.