deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT03164967

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16

A Phase IV, Multicenter, Open-label Study to Evaluate the Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Disorders in Subjects Aged 2 to 16

Sponsor: ADMA Biologics, Inc.

Conditions Humoral Immune Response
Interventions Bivigam
Updated 11 times since 2017 Last updated: Jan 30, 2023 Started: Dec 29, 2016 Primary completion: Aug 30, 2022 Completion: Dec 31, 2022
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 Humoral Immune Response and is currently completed. ADMA Biologics, Inc. leads this study, which shows 11 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jun 2017 – ~Mar 2018 · 9 months · monthly snapshotRecruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotRecruiting~Jun 2018 – ~Aug 2020 · 26 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshotRecruiting~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshotActive Not Recruiting~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  5. Sep 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

▶ Show 6 earlier versions

  1. Sep 2021 — Sep 2022 [monthly]

    Recruiting PHASE4

  2. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE4

  3. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  4. Jun 2018 — Aug 2020 [monthly]

    Recruiting PHASE4

  5. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  6. Jun 2017 — Mar 2018 [monthly]

    Recruiting PHASE4

    First recorded

Dec 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • ADMA Biologics, Inc.
Data source: ADMA Biologics, Inc.

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

Study Locations