Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
1 other identifier
interventional
15
1 country
6
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 substitution therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2001
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedApril 19, 2007
April 1, 2007
August 29, 2005
April 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Safety of IVIG-L in patients with hypogammaglobulinemia
Secondary Outcomes (2)
To compare the IgG trough level
To compare dosage and treatment intervals
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Medical Centre Alkmaar
Alkmaar, 1815 JD, Netherlands
Academic Medical Centre
Amsterdam, 1100 DD, Netherlands
Academic Hospital Groningen
Groningen, 9700 RB, Netherlands
LUMC
Leiden, 2333 ZA, Netherlands
UMC St. Radboud
Nijmegen, 6525 GA, Netherlands
Leyenburg Hospital
The Hague, 2545 CH, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J WM van der Meer, MD, PhD
UMC St Radboud Nijmegen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
May 1, 2001
Study Completion
December 1, 2004
Last Updated
April 19, 2007
Record last verified: 2007-04