Efficacy and Safety of IVIG-L in ITP Patients

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

Official title:

Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151840
• Other study ID #: KB98001
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: January 30, 2006
• Start date: October 2001
• Est. completion date: March 2002

Study information

• Verified date: January 2006
• Source: Sanquin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• IVIG-L

Locations

Country	Name	City	State
Poland	Hematology Clinic, Medical University of Bialystok	Bialystok
Poland	Haematology Clinic, Medical University of Gdansk	Gdansk
Poland	Clinic of Haematology, Medical University of Lodz	Lodz
Poland	Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy	Warsaw
Poland	Haematology Clinic, Medical University of Warsaw	Warsaw
Poland	Institute of Haematology and Transfusiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of IVIG-L
Primary	The safety of IVIG-L
Secondary	To compare data on efficacy and safety of IVIG-L with data obtained from literature