BAX 326 Surgery

• Research type

  Research Study

• Full title

  BAX 326 (recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients with Severe (FIX level less than 1%) or Moderately Severe (FIX level less than or equal to 2%) Hemophilia B undergoing Surgical or Other Invasive Procedures

• IRAS ID

  83871

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Baxter Inovations GmbH

• Eudract number

  2011-000413-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Baxter Healthcare Corporation has developed a product named BAX 326 (recombinant human factor IX, rFIX) intended for prophylactic and treatment of bleeding episodes in hemophilia B patients. BAX 326 is similar to the product BeneFIX marketed by Pfizer.This study is a Phase 3, open-label, multicentre study in subjects with haemophilia B undergoing planned or emergency surgical, dental or other invasive procedures. The main objective of the study is to assess how well BAX326 helps controlling bleeding episodes (haemostatic efficacy) and how safe it is in haemophilia B patients undergoing surgical procedures. After signing the informed consent form patients will start with the screening visit. If patients have not participated in the pharmacokinetic assessment during other BAX studies or enter this study directly they will have a pharmacokinetic assessment after the screening visit. In PK assessment patients will receive an infusion of BAX 326 and blood samples will be taken to determine how BAX326 is distributed and eliminated. After the screening visit (and the pharmacokinetic assessment, if applicable) patients will receive treatment with BAX 326 prior, during and after the surgery. Patients will be closely monitored to evaluate the efficacy and safety of BAX 326. Safety assessments (vital signs, physical examinations, blood tests and urine tests) and immunology tests to detect factor IX inhibitors and antibodies will be performed. Patients will be monitored during the whole study for any undesirable medical events. Additional safety assessments may be done whenever they are needed as determined by the investigator. The duration of participation for each subject depends on the nature of the invasive procedure: it will run from the signing of the informed consent form until discharge from the hospital.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/1238

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion