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Status:

COMPLETED

Efficacy and Safety of IVIG-L in ITP Patients

Lead Sponsor:

Prothya Biosolutions

Conditions:

Purpura, Thrombocytopenic, Idiopathic

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 immunogl...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2001

Trial Type :

INTERVENTIONAL

End Date :

March 1 2002

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00151840

Start Date

October 1 2001

End Date

March 1 2002

Last Update

January 31 2006

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

Hematology Clinic, Medical University of Bialystok

Bialystok, Poland, 15-276

2

Haematology Clinic, Medical University of Gdansk

Gdansk, Poland, 80-952

3

Clinic of Haematology, Medical University of Lodz

Lodz, Poland, 93-509

4

Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy

Warsaw, Poland, 00-909