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

April 18, 2007 updated by: Prothya Biosolutions

Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To compare the IgG trough level
To compare dosage and treatment intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prothya Biosolutions

Investigators

  • Principal Investigator: J WM van der Meer, MD, PhD, UMC St Radboud Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (ESTIMATE)

August 30, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB97003 (A & B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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