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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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 > 115┬Ámol/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 efficacy of IVIG-L
The safety 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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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