Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
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.
Lead SponsorSymphogen A/S
StatusCompleted No Results Posted
Indication/ConditionImmune Thrombocytopenic Purpura
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.
Each cohort will receive one single dose of Sym001 according the assigned dose level.
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.