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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S
• Collaborator: Swedish Orphan Biovitrum

Criteria

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.