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

Hypogammaglobulinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138697
• Other study ID #: KB97003 (A & B)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 29, 2005
• Last updated: April 18, 2007
• Start date: May 2001
• Est. completion date: December 2004

Study information

• Verified date: April 2007
• Source: Sanquin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agammaglobulinemia
• Hypogammaglobulinemia

Intervention

Drug:
• IVIG-L

Locations

Country	Name	City	State
Netherlands	Medical Centre Alkmaar	Alkmaar
Netherlands	Academic Medical Centre	Amsterdam
Netherlands	Academic Hospital Groningen	Groningen
Netherlands	LUMC	Leiden
Netherlands	UMC St. Radboud	Nijmegen
Netherlands	Leyenburg Hospital	The Hague

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of IVIG-L in patients with hypogammaglobulinemia
Primary	Efficacy of IVIG-L in patients with hypogammaglobulinemia
Primary	Safety of IVIG-L in patients with hypogammaglobulinemia
Secondary	To compare the IgG trough level
Secondary	To compare dosage and treatment intervals