Efficacy and Safety of IVIG-L in ITP Patients - Full Text View

Sponsored by:	Sanquin
Information provided by:	Sanquin
ClinicalTrials.gov Identifier:	NCT00151840

Purpose

The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.

Condition	Intervention	Phase
Purpura, Thrombocytopenic, Idiopathic	Drug: IVIG-L	Phase III

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

Further study details as provided by Sanquin:

Primary Outcome Measures:

The efficacy of IVIG-L
The safety of IVIG-L

Secondary Outcome Measures:

To compare data on efficacy and safety of IVIG-L with data obtained from literature

Estimated Enrollment:	20
Study Start Date:	October 2001
Estimated Study Completion Date:	March 2002

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 infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage.

In addition to donor selection and screening, several procedures have been included in the production process to improve viral safety.

In this clinical trial, the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature. IVIG-L will also be studied in patients with hypogammaglobulinemia.The results from both studies will be used for an application for marketing authorisation of IVIG-L 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:

Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding
Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery
A stable clinical situation (no activity of any other disease)
Age at least 18 yrs
The patient/legally acceptable representative has signed the consent form

Exclusion Criteria:

The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis
Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV)
Massive splenomegaly
Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
Having an ongoing progressive terminal disease, including HIV infection
Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin
Presence of conditions predisposing for bleeding: anaemia (hemoglobin < 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole > 110 mm Hg).
Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included
Splenectomy in the previous two weeks
Renal insufficiency (plasma creatinine > 115µmol/L)
Pregnancy or lactation
Known with insufficiency of coronary or cerebral circulation
IgA deficiency and anti-IgA antibodies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151840

Locations

Poland
Hematology Clinic, Medical University of Bialystok
Bialystok, Poland, 15-276
Institute of Haematology and Transfusiology
Warsaw, Poland, 00-957
Clinic of Haematology, Medical University of Lodz
Lodz, Poland, 93-509
Haematology Clinic, Medical University of Gdansk
Gdansk, Poland, 80-952
Haematology Clinic, Medical University of Warsaw
Warsaw, Poland, 02-097
Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy
Warsaw, Poland, 00-909

Sponsors and Collaborators

Sanquin

Investigators

Study Director:

P FW Strengers, MD

Sanquin

More Information

Study ID Numbers:	KB98001
Study First Received:	September 8, 2005
Last Updated:	January 30, 2006
ClinicalTrials.gov Identifier:	NCT00151840
Health Authority:	Poland: Ministry of Health

Keywords provided by Sanquin:

Purpura, Thrombocytopenic, Idiopathic
ITP
Immunoglobulin, Intravenous

Study placed in the following topic categories:

Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic
Signs and Symptoms

Thrombocytopathy
Antibodies
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic
Immunoglobulins

Additional relevant MeSH terms:

Skin Manifestations
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009