Back to resultsKinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Primary Purpose
Hypogammaglobulinemia
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
IVIG-L
Sponsored by
About this trial
This is an interventional treatment trial for Hypogammaglobulinemia focused on measuring Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- Medical Centre Alkmaar
- Academic Medical Centre
- Academic Hospital Groningen
- LUMC
- UMC St. Radboud
- Leyenburg Hospital
Outcomes
Primary Outcome Measures
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 Outcome Measures
To compare the IgG trough level
To compare dosage and treatment intervals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00138697
Brief Title
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Official Title
Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prothya Biosolutions
4. Oversight
5. Study Description
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.
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 immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage.
In addition to the donor selection and donor screening, several viral safety steps have been included into the production process.
In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogammaglobulinemia
Keywords
Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IVIG-L
Primary Outcome Measure Information:
Title
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Title
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Title
Safety of IVIG-L in patients with hypogammaglobulinemia
Secondary Outcome Measure Information:
Title
To compare the IgG trough level
Title
To compare dosage and treatment intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J WM van der Meer, MD, PhD
Organizational Affiliation
UMC St Radboud Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Academic Medical Centre
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Academic Hospital Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Leyenburg Hospital
City
The Hague
ZIP/Postal Code
2545 CH
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
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