Status:
COMPLETED
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Lead Sponsor:
Prothya Biosolutions
Conditions:
Hypogammaglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin...
Detailed Description
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunogl...
Eligibility Criteria
Inclusion
- Primary a- or hypogammaglobulinemia, particularly patients with X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
- Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose)
- Age \> 18 years
- The patient/legally acceptable representative has signed the consent form
Exclusion
- Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- Known allergic reactions to human plasma or plasma products
- Have an ongoing progressive terminal disease, including HIV infection
- Pregnancy or lactation
- Known insufficiency of coronary or cerebral circulation
- Have renal insufficiency (plasma creatinine \> 115µmol/L)
- Have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection.
- Have IgA deficiency, and anti-IgA antibodies have been detected
- Active systemic lupus erythematosus (SLE)
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00138697
Start Date
May 1 2001
End Date
December 1 2004
Last Update
April 19 2007
Active Locations (6)
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1
Medical Centre Alkmaar
Alkmaar, Netherlands, 1815 JD
2
Academic Medical Centre
Amsterdam, Netherlands, 1100 DD
3
Academic Hospital Groningen
Groningen, Netherlands, 9700 RB
4
LUMC
Leiden, Netherlands, 2333 ZA