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

NCT03961009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-05-05

Study results available
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Summary

The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).

Conditions

  • Primary Immunodeficiency Disease

Interventions

BIOLOGICAL

Kedrion IVIG 10%

Kedrion intravenous immunoglobulin (IVIg) 10%

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Kedrion SpA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-12-21
Completion
2020-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961009 on ClinicalTrials.gov