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

Bio Products Laboratory

Status and phase: Completed; Phase 4

Conditions: Primary or Secondary Antibody Deficiency

Treatments: Biological: Vigam® (Human Normal Immunoglobulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02247154

VIGPSAD

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Vigam® Liquid

Experimental group

Treatment:

Biological: Vigam® (Human Normal Immunoglobulin)