To evaluate safety,kinetics&dynamics of Solulin in hemophilia patients

• Research type

  Research Study

• Full title

  A Phase I Dose Finding Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Single intravenous Doses of Solulin in Volunteers with Severe Hemophilia A receiving Regular Prophylactic Treatment with Coagulation Factor VIII

• IRAS ID

  78062

• Contact name

  Tim Mant

• Sponsor organisation

  PAION Deutschland GmbH

• Eudract number

  2011-000851-17

• Research summary

  The drug being tested in this trial is Solulin. It is hoped that Solulin will be effective in improving the treatment of haemophilia. In this study we are investigating the effects of different doses of Solulin in patients with severe haemophilia who are taking prophylactic treatment with factor VIII. This includes effects on blood clotting, concentration of Factor VIII, tolerability, safety and how Solulin is broken down and eliminated by the body in patients with haemophilia. We will use single intravenous doses of Solulin during the study, and follow up observation of patients will be 6 months. This phase I study serves the purpose to define a dose for a Phase II study with multiple dosing as is required for this chronic disease. Multiple dosing has been demonstrated to be safe in the first-in-man study in healthy adult volunteers. The study will involve a maximum of 24 male haemophilia patients. For each subject the maximum duration will be 6 months and 21 days.The study will take place at Quintiles Drug Research Unit at Guy's Hospital.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/0270

• Date of REC Opinion

  3 May 2011

• REC opinion

  Favourable Opinion