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

A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02247154

Enrollment

Unknown

Registered

2014-09-23

Start date

1999-04-30

Completion date

Unknown

Last updated

2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary or Secondary Antibody Deficiency

Brief summary

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.

Interventions

BIOLOGICALVigam® (Human Normal Immunoglobulin)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
IgG half-life	Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026