Clinical trial NCT00151840: Efficacy and Safety of IVIG-L in ITP Patients
Official title: Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Purpura, Thrombocytopenic, Idiopathic
Keywords: Purpura, Thrombocytopenic, Idiopathic
ITP
Immunoglobulin, Intravenous
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The efficacy of IVIG-L
measure: The safety of IVIG-L
Secondary outcomes:
measure: To compare data on efficacy and safety of IVIG-L with data obtained from literature
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Hematology Clinic, Medical University of Bialystok
city: Gdansk
country: Poland
facility: Haematology Clinic, Medical University of Gdansk
city: Lodz
country: Poland
facility: Clinic of Haematology, Medical University of Lodz
city: Warsaw
country: Poland
facility: Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy
city: Warsaw
country: Poland
facility: Institute of Haematology and Transfusiology
city: Warsaw
country: Poland
facility: Haematology Clinic, Medical University of Warsaw
Study officials:
affiliation: Prothya Biosolutions
name: P FW Strengers, MD
role: STUDY_DIRECTOR
References: