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

• Sponsor: Prothya Biosolutions (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00138697
• Collaborator: (none)
• Enrollment: 15
• Locations: 6
• Duration (Months): 43
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypogammaglobulinemia	Drug: IVIG-L	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
• Study Start Date: May 1, 2001
• Actual Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. Kinetics of IVIG-L in patients with hypogammaglobulinemia []

2. Efficacy of IVIG-L in patients with hypogammaglobulinemia []

3. Safety of IVIG-L in patients with hypogammaglobulinemia []

Secondary Outcome Measures

1. To compare the IgG trough level []

2. To compare dosage and treatment intervals []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Medical Centre Alkmaar	Alkmaar		Netherlands	1815 JD
2	Academic Medical Centre	Amsterdam		Netherlands	1100 DD
3	Academic Hospital Groningen	Groningen		Netherlands	9700 RB
4	LUMC	Leiden		Netherlands	2333 ZA
5	UMC St. Radboud	Nijmegen		Netherlands	6525 GA
6	Leyenburg Hospital	The Hague		Netherlands	2545 CH

Sponsors and Collaborators

• Prothya Biosolutions

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00138697
• Other Study ID Numbers: KB97003 (A & B)
• First Posted: Aug 30, 2005
• Last Update Posted: Apr 19, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Agammaglobulinemia; Hypogammaglobulinemia; Immunoglobulins, Intravenous
• Additional relevant MeSH terms: Agammaglobulinemia

Study Results

No Results Posted as of Apr 19, 2007