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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Primary Immune Deficiency Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IGIV-SN

Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)

Group Type EXPERIMENTAL

Immunoglobulin

Intervention Type BIOLOGICAL

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

Interventions

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Immunoglobulin

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

Intervention Type BIOLOGICAL

Other Intervention Names

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IGIV-SN

Eligibility Criteria

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Inclusion Criteria

* Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
* Subject is willing to comply with all requirements of protocol
* Authorization to access personal health information

Exclusion Criteria

* Subject has secondary immunodeficiency
* Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
* Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

Minimum Eligible Age

24 Months

Maximum Eligible Age

203 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No