A Phase I Study of KW-3357 in Congenital Antithrombin Deficiency

• Research type

  Research Study

• Full title

  A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of a Single Dose (50 IU/kg) of KW 3357 in Subjects with Congenital Antithrombin Deficiency.

• IRAS ID

  13435

• Contact name

  Beverley Hunt

• Sponsor organisation

  Kyowa Hakko Kirin UK Ltd

• Eudract number

  2008-005504-16

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  Antithrombin is a protein which naturally occurs in the blood, and plays an important role in regulating blood clotting. It helps to thin blood, but in some people who have antithrombin deficiency, there is not enough present and so they can be at increased risk of developing blood clots in their veins. There are very few medicines available to treat this condition. This research study investigated an experimental medicine called KW-3357. KW-3357 is a man-made substance which is produced in a laboratory, and it is very similar to antithrombin. By replacing the missing antithrombin in people who have antithrombin deficiency with KW-3357, it is hoped that the new medicine will temporarily correct the antithrombin deficiency and prevent clots forming in blood vessels when they are not needed to stop bleeding. People who have inherited antithrombin deficiency (but who currently have no symptoms), were invited to take part in this study. Participants were screened, and if eligible, received one dose of KW-3357, which was given directly into the vein (this is called an Ó?intravenous infusion?). There were a series of assessments and follow-up visits, with each participant being in the study for about 4 months. The study was designed to investigate the amount of KW-3357 in the blood stream and how the body removes it. It also looked to see how safe it is and what side effects occured. The results are currently being analysed.The study was sponsored by Kyowa Hakko Kirin UK Ltd. A total of 16 participants were enrolled in Europe.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/3

• Date of REC Opinion

  11 Feb 2009

• REC opinion

  Favourable Opinion