Pharmacokinetic and Outcome Study of a Factor IX Product.

• Research type

  Research Study

• Full title

  Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Hemophilia B

• IRAS ID

  6236

• Contact name

  Peter Collins

• Eudract number

  2007-005100-41

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  NCT00768287

• Research summary

  The first part of the study compares how the already marketed product BeneFIX© works in the body (pharmacokinetic effect) compared to the new Investigational product IB1001 in subjects with haemophilia B. Subjects will be randomized to receive either a single dose of BeneFIX© or IB1001. Factor IX measurements are taken at incremental time points following the infusion. 5-28 days later, a single dose of the opposite product is given and identical factor IX measurements taken.Subjects who are ineligible for this initial pharmacokinetic study will enter a recovery study instead. All subjects who fulfil the entry criteria will then enter the long-term treatment phase where treatment maybe taken either for prevention or on an as-needed basis for a period of 6 months. Follow up visits will be required at 3 and 6 month time points. During this treatment phase, if subjects are due to undergo surgery, a sub-study can be undertaken which aims to see the effect on bleeding control for subjects undergoing major surgery. Subjects will be supported during surgery with either a continuous or bolus doses of IB1001. Factor IX measurements are taken at incremental time points throughout the surgical procedure and recovery period.Subjects may also be enrolled solely into the surgical sub-study and are not required to participate in any other sections of the study. These subjects will be required to meet all screening and eligibility criteria.At the end of the study, subjects will be given the opportunity to enter the continuation study where they will receive IB1001 from the commercial preparation for up to one year. Follow up visits identical to the treatment phase will be performed every three months for one year. If participating in both the Treatment and Continuation phases, subjects will be in the study for a total of 18 months.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/2

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Further Information Favourable Opinion