Status:
COMPLETED
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Lead Sponsor:
Bio Products Laboratory
Conditions:
Primary or Secondary Antibody Deficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 de...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02247154
Start Date
April 1 1999
Last Update
February 15 2018
Active Locations (8)
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1
Papworth Hospital
Papworth Everard, Cambridgeshire, United Kingdom
2
Cardiff Royal Infirmary
Cardiff, United Kingdom
3
Leicester Royal Infirmary
Leicester, United Kingdom
4
Royal Brompton Hospital
London, United Kingdom