A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®

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

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Brief Summary

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The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.

The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.

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Detailed Description

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Conditions

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Primary Antibody Deficiency

Study Groups

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Subgam®

Group Type EXPERIMENTAL

Subgam® (Human Normal Immunoglobulin Solution)

Intervention Type BIOLOGICAL

Interventions

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Subgam® (Human Normal Immunoglobulin Solution)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* The main criteria for inclusion in the study were as follows:

* A diagnosis of primary antibody deficiency;
* No lower or upper age limit (any age was eligible);
* With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
* Written informed consent (patient/parent/guardian).