Back to resultsA Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Primary Purpose
Primary or Secondary Antibody Deficiency
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Vigam® (Human Normal Immunoglobulin)
Sponsored by
About this trial
This is an interventional treatment trial for Primary or Secondary Antibody Deficiency
Eligibility Criteria
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:
-
Sites / Locations
- Papworth Hospital
- Cardiff Royal Infirmary
- Leicester Royal Infirmary
- Royal Brompton Hospital
- Royal Free Hospital
- Royal Victoria Infirmary
- Hospital of St Cross
- Taunton & Somerset Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vigam® Liquid
Arm Description
Outcomes
Primary Outcome Measures
IgG half-life
Secondary Outcome Measures
Full Information
NCT ID
NCT02247154
First Posted
September 2, 2014
Last Updated
February 14, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02247154
Brief Title
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Official Title
A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. Study Description
Brief Summary
To determine:
The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
The half-life of Vigam® Liquid after 4 months of treatment.
The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary or Secondary Antibody Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
Vigam® Liquid
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Vigam® (Human Normal Immunoglobulin)
Primary Outcome Measure Information:
Title
IgG half-life
Time Frame
Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Papworth Hospital
City
Papworth Everard
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Cardiff Royal Infirmary
City
Cardiff
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle
Country
United Kingdom
Facility Name
Hospital of St Cross
City
Rugby
Country
United Kingdom
Facility Name
Taunton & Somerset Hospital
City
Somerset
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
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