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Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

NCT03492710 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-07

No results posted yet for this study

Summary

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Conditions

  • Primary Immune Deficiency Disorder

Interventions

BIOLOGICAL

Immunoglobulin

Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Chaim Roifman · The Hospital for Sick Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Months
Max Age
203 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

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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 NCT03492710 on ClinicalTrials.gov