deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT03961009

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients (CARES10)

A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients

Sponsor: Kedrion S.p.A.

Interventions Kedrion IVIG 10%
Updated 9 times since 2019 Last updated: Mar 25, 2025 Started: Apr 30, 2019 Primary completion: Dec 21, 2020 Completion: Dec 21, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Primary Immunodeficiency Disease, this trial is completed. The trial is conducted by Kedrion S.p.A. and has accumulated 9 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2019 – ~Oct 2020 · 16 months · monthly snapshotRecruiting~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshotActive Not Recruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotActive Not Recruiting~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotActive Not Recruiting~Jun 2021 – ~Feb 2022 · 8 months · monthly snapshotCompleted~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~May 2025 · 8 months · monthly snapshotCompleted~May 2025 – present · 14 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. May 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — May 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Feb 2022 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2021 — Feb 2022 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Jan 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  3. Oct 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  4. Jun 2019 — Oct 2020 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2019

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kedrion S.p.A.
Data source: Kedrion S.p.A.

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