Efficacy and Safety of IVIG-L in ITP Patients

This study has been completed.
Sponsor:
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00151840
First received: September 8, 2005
Last updated: January 30, 2006
Last verified: January 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Poland
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
Haematology Clinic, Medical University of Warsaw
Warsaw, Poland, 02-097
Institute of Haematology and Transfusiology
Warsaw, Poland, 00-957
Sponsors and Collaborators
Sanquin
Investigators
Study Director: P FW Strengers, MD Sanquin
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 29, 2014