deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01465958

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency (KIDS)

An Open-label, Single-sequence, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Subcutaneous GAMUNEX®-C in Pediatric Subjects With Primary Immunodeficiency

Sponsor: Grifols Therapeutics LLC

Interventions GAMUNEX-C
Updated 7 times since 2017 Last updated: Feb 23, 2015 Started: Nov 30, 2011 Primary completion: Oct 31, 2013 Completion: Oct 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01465958, this PHASE4 trial focuses on Primary Immunodeficiency and remains completed. Sponsored by Grifols Therapeutics LLC, it has been updated 7 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 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

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Apr 2018 — Jun 2018 [monthly]

    Completed PHASE4

Show 2 earlier versions
  1. Feb 2017 — Apr 2018 [monthly]

    Completed PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Nov 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
Data source: Grifols Therapeutics LLC

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