A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency

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

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Brief Summary

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To determine:

1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
3. The half-life of Vigam® Liquid after 4 months of treatment.
4. The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.

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Detailed Description

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Conditions

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Primary or Secondary Antibody Deficiency

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Vigam® Liquid

Group Type EXPERIMENTAL

Vigam® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Interventions

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Vigam® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults (18-80 years) with PAD or SAD
* With a low serum IgG (\<6 g/l) and a history of recurrent infections
* Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
* Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial