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

NCT ID: NCT00138697

Last Updated: 2007-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Hypogammaglobulinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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IVIG-L

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prothya Biosolutions

INDUSTRY

Sponsor Role lead

Principal Investigators

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J WM van der Meer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud Nijmegen

Locations

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Medical Centre Alkmaar

Alkmaar, , Netherlands

Site Status

Academic Medical Centre

Amsterdam, , Netherlands

Site Status

Academic Hospital Groningen

Groningen, , Netherlands

Site Status

LUMC

Leiden, , Netherlands

Site Status

UMC St. Radboud

Nijmegen, , Netherlands

Site Status

Leyenburg Hospital

The Hague, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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KB97003 (A & B)

Identifier Type: -

Identifier Source: org_study_id