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

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Primary or Secondary Antibody Deficiency

Interventions

Vigam® (Human Normal Immunoglobulin)BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: \-

Locations (8)

Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

Cardiff Royal Infirmary

Cardiff, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Outcomes

Primary Outcomes

IgG half-life

Time frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose

Data from ClinicalTrials.gov

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