Trial of Sym001 in the treatment of Immune Thrombocytopenic Purpura

• Research type

  Research Study

• Full title

  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

• IRAS ID

  59733

• Sponsor organisation

  Symphogen A/S

• Eudract number

  2007-006081-15

• ISRCTN Number

  finished

• Research summary

  The trial of drug known as Sym001 will be conducted in a multi-centre study for the treatment of patients with Immune Thrombocytopenic Purpura (ITP). Sym001 is a new recombinant, human, antigen-specific polyclonal antibody product that is directed against the Rhesus D (RhD) antigen. In simpler terms the drug is a collection of antibodies designed to attach themselves to the Rhesus antigen thereby preventing the destruction of platelets. The purpose of the research project is to understand how safe different doses of Sym001 are and also to see how effective the drug is at increasing the subjects platelet count. A total of 66 patients will enter this trial; each patient will receive a single intravenous (through the vein) dose of the drug. There will be ten different dose levels given as the trial progresses. Each patient will be aware of the dose they are due to receive before the injection or infusion is given. After the dose is given the patient will attend 8 further visits during which a number of assessments and blood samples will be taken. The patient will remain in the study for 6 weeks, this is to allow the study doctor and sponsor (company funding the research) to assess the safety and effectiveness of the drug.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/47

• Date of REC Opinion

  25 Oct 2010

• REC opinion

  Further Information Favourable Opinion