deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT00634569

Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.

Sponsor: Instituto Grifols, S.A.

Interventions Flebogamma 5% DIF
Updated 7 times since 2017 Last updated: Dec 7, 2016 Started: May 31, 2008 Primary completion: Mar 31, 2011 Completion: May 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Primary Immune Deficiency Disease and is currently completed. Instituto Grifols, S.A. leads this study, which shows 7 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~May 2019 · 11 months · monthly snapshotCompleted~May 2019 – ~Jan 2021 · 20 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 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. May 2019 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jun 2018 — May 2019 [monthly]

    Completed PHASE4

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

    Completed PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

May 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Instituto Grifols, S.A.
Data source: Grifols Biologicals, LLC

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