Efficacy and Safety of IVIG-L in ITP Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00151840
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Sanquin
• Public title: Efficacy and Safety of IVIG-L in ITP Patients
• Scientific title: Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
• Date of first enrolment: October 2001
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00151840
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Poland

Contacts

• Name: P FW Strengers, MD
• Affiliation: Sanquin

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Purpura, Thrombocytopenic, Idiopathic

Intervention(s)

Drug: IVIG-L

Primary Outcome(s)

The safety of IVIG-L

The efficacy of IVIG-L

Secondary Outcome(s)

To compare data on efficacy and safety of IVIG-L with data obtained from literature

Secondary ID(s)

KB98001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors