Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients - Full Text View

Sponsored by:	Sanquin
Information provided by:	Sanquin
ClinicalTrials.gov Identifier:	NCT00138697

Purpose

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.

Condition	Intervention	Phase
Hypogammaglobulinemia	Drug: IVIG-L	Phase II Phase III

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients

Further study details as provided by Sanquin:

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

Estimated Enrollment:	15
Study Start Date:	May 2001
Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138697

Locations

Netherlands
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Academic Medical Centre
Amsterdam, Netherlands, 1100 DD
Academic Hospital Groningen
Groningen, Netherlands, 9700 RB
Medical Centre Alkmaar
Alkmaar, Netherlands, 1815 JD
Leyenburg Hospital
The Hague, Netherlands, 2545 CH
LUMC
Leiden, Netherlands, 2333 ZA

Sponsors and Collaborators

Sanquin

Investigators

Principal Investigator:

J WM van der Meer, MD, PhD

UMC St Radboud Nijmegen

More Information

Study ID Numbers:	KB97003 (A & B)
Study First Received:	August 29, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00138697
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin:

Agammaglobulinemia
Hypogammaglobulinemia
Immunoglobulins, Intravenous

Study placed in the following topic categories:

Lymphatic Diseases
Antibodies
Agammaglobulinemia
Immunoglobulins, Intravenous
Hematologic Diseases

Blood Protein Disorders
Rho(D) Immune Globulin
Lymphoproliferative Disorders
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009