deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT01467947

Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

Prospective Open-label Uncontrolled Multi-center Post-marketing Study to Assess Inhibitory Antibody Formation in Subjects With Congenital C1-INH Deficiency and Acute Hereditary Angioedema (HAE) Attacks Treated With Berinert® , a C1-esterase Inhibitor

Sponsor: CSL Behring

Updated 8 times since 2017 Last updated: Dec 12, 2016 Started: Nov 30, 2011 Primary completion: Oct 31, 2014 Completion: Oct 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01467947, this PHASE4 trial focuses on Hereditary Angioedema Types I and II and remains completed. Sponsored by CSL Behring, it has been updated 8 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 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

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

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE4

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE4

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE4

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. 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:
  • CSL Behring
Data source: CSL Behring

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