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NCT04944979 · ClinicalTrials.gov registry record · Phase 3

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)

A Phase 3 study of Primary Immunodeficiency Disease, sponsored by Kedrion S.p.A..

Active
Registry status
Phase 3
Development phase
30
Enrollment target
20
Study locations

NCT04944979 is a Phase 3 study of Primary Immunodeficiency Disease that is active but no longer recruiting, run by Kedrion S.p.A.. The registered enrollment target is 30 participants. The trial reports 20 study locations across 8 states.

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The verdict

NCT04944979, a Phase 3 study of Primary Immunodeficiency Disease, is active but no longer recruiting, sponsored by Kedrion S.p.A..

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
30 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).

Interventions

  • BIOLOGICAL Kedrion IVIG 10%

Study Locations (20)

Other

  • Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet - Budapest
  • SST Spedali Civili di Brescia - Brescia
  • Azienda Ospedaliero-Universitaria - Ospedale Pediatrico Meyer - Florence
  • I.R.C.C.S. Istituto Giannina Gaslini - Genova
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinic - Milan
  • Azienda Ospedaliera Universitaria "Federico II" - Naples
  • Fondazione Policlinico Tor Vergata - Roma
  • IRCCS Ospedale Pediatrico Bambino Gesù - Roma
  • Centro Hospitalar Lisboa Central - Hospital Dona Estefânia - Lisbon
  • Centro Hospitalar Universitário do Porto - Hospital Santo António - Porto
  • Children's City Clinical Hospital No. 9 named after G.N. Speransky, Moscow City Health Department - Moscow
  • Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology - Moscow

Louisiana

  • Velocity Clinical Research - MedPharmics - Lafayette - Lafayette
  • Louisiana State University Shreveport - Shreveport

California

  • Benioff Children's Hospital - Mission Bay - San Francisco

Colorado

  • IMMUNOe Health and Research Centers - Centennial

Florida

  • Johns Hopkins All Children's Hospital - St. Petersburg

North Carolina

  • Duke Children's Hospital & Health Center - Durham

Ohio

  • Asthma and Allergy Center - Toledo - Toledo

Oklahoma

  • Vital Prospects Clinical Research Institute PC - Tulsa

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-03-31
Est. Completion 2026-10-30
Phase Phase 3

Sponsor

Kedrion S.p.A.

8 total trials

What the Registry Record Tells You About NCT04944979

The ClinicalTrials.gov registry entry for NCT04944979 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kedrion S.p.A., which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Immunodeficiency Disease appearing as the primary indexed condition, and to 1 intervention - of which Kedrion IVIG 10% is the first listed.

NCT04944979 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Louisiana, California.

Frequently Asked Questions

What is clinical trial NCT04944979 about?

NCT04944979 is a clinical study titled "Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)". The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).

What is the current status of trial NCT04944979?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2021-03-31. Estimated completion is 2026-10-30.

What conditions does trial NCT04944979 study?

This clinical trial studies the following conditions: Primary Immunodeficiency Disease.

What interventions are being tested in trial NCT04944979?

The interventions under investigation include: Kedrion IVIG 10% (BIOLOGICAL).

Who is sponsoring clinical trial NCT04944979?

This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04944979 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.