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

Primary or Secondary Antibody Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247154
• Other study ID #: VIGPSAD
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2014
• Last updated: February 14, 2018
• Start date: April 1999

Study information

• Verified date: February 2018
• Source: Bio Products Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Primary or Secondary Antibody Deficiency

Intervention

Biological:
• Vigam® (Human Normal Immunoglobulin)

Locations

Country	Name	City	State
United Kingdom	Cardiff Royal Infirmary	Cardiff
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle
United Kingdom	Papworth Hospital	Papworth Everard	Cambridgeshire
United Kingdom	Hospital of St Cross	Rugby
United Kingdom	Taunton & Somerset Hospital	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
Bio Products Laboratory

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

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