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

This study has been completed.
Sponsor:
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00138697
First received: August 29, 2005
Last updated: April 18, 2007
Last verified: April 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Medical Centre Alkmaar
Alkmaar, Netherlands, 1815 JD
Academic Medical Centre
Amsterdam, Netherlands, 1100 DD
Academic Hospital Groningen
Groningen, Netherlands, 9700 RB
LUMC
Leiden, Netherlands, 2333 ZA
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Leyenburg Hospital
The Hague, Netherlands, 2545 CH
Sponsors and Collaborators
Sanquin
Investigators
Principal Investigator: J WM van der Meer, MD, PhD UMC St Radboud Nijmegen
  More Information

No publications provided

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

Keywords provided by Sanquin:
Agammaglobulinemia
Hypogammaglobulinemia
Immunoglobulins, Intravenous

Additional relevant MeSH terms:
Agammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014