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Efficacy and Safety of IVIG-L in ITP Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00151840
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 31, 2006
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Purpura, Thrombocytopenic, Idiopathic Drug: IVIG-L 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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
Study Start Date : October 2001
Estimated Study Completion Date : March 2002

Primary Outcome Measures :
  1. The efficacy of IVIG-L
  2. The safety of IVIG-L

Secondary Outcome Measures :
  1. To compare data on efficacy and safety of IVIG-L with data obtained from literature

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151840

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

ClinicalTrials.gov Identifier: NCT00151840     History of Changes
Other Study ID Numbers: KB98001
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: January 31, 2006
Last Verified: January 2006

Keywords provided by Sanquin:
Purpura, Thrombocytopenic, Idiopathic
Immunoglobulin, Intravenous

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs