Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)



Status:Completed
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:July 2008
End Date:October 2011

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A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label
trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will
receive a single IV dose of Sym001.


Inclusion Criteria:

- Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the
pre-dose visit.

- History of isolated ITP

- RhD-positive serology.

- Previous treatment and response to first line therapy for ITP

Exclusion Criteria:

- Known clinical picture suggestive of other causes of thrombocytopenia, especially
systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome,
immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of
drugs such as quinidine/quinine, heparin and sulfonamides and hereditary
thrombocytopenia confirmed by relevant laboratory findings.

- Suspected infection with HIV, Hepatitis C, H. pylori.

- Clinical splenomegaly

- History of abnormal bone marrow examination.

- Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.

- Underlying haemolytic condition

- History of splenectomy.

- Subject is pregnant, breast feeding or intends to become pregnant.
We found this trial at
4
sites
1001 Physicians Drive
Charleston, South Carolina 29414
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Brugge,
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Omaha, Nebraska 68198
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Omaha, NE
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