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

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.