Efficacy and Safety of IVIG-L in ITP Patients

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Antibodies; Immunoglobulins

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