Clinical Trial: Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Sub

Brief Summary: The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.

Detailed Summary:
Sponsor: Octapharma

Current Primary Outcome: Overall clinical assessment of the haemostatic efficacy of Octafibrin in treating the first documented bleeding episode of each patient [ Time Frame: 24 hrs after last infusion for each bleeding episode ]

The first bleeding episode covers the time period from the first Octafibrin infusion until 24 hours (i.e., 1 day) after the last infusion.

The investigator's overall clinical assessment of haemostatic efficacy for bleeding will be based on a 4 point haemostatic efficacy scale. The final efficacy assessment of each patient will be adjudicated by the Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC). The number of subjects per outcome category will be assessed in the final analysis.



Original Primary Outcome: Same as current

Current Secondary Outcome: Overall clinical assessment of the haemostatic efficacy of Octafibrin used during and after surgery [ Time Frame: end of surgery and 1 hour after last post-op infusion ]

An overall efficacy assessment taking both the intra- and post-operative assessment into account will be adjudicated by the IDMEAC. The location, severity and type of surgery will be documented. Expected and actual duration of surgical procedure and details of administered dose(s) of Octafibrin (pre-, intra- and/or post-operatively) will be recorded. Fibrinogen plasma levels (pre-, intra-, and post-operatively) will be measured. Details of concomitantly administered products (except standard anaesthesia) along with a brief narrative describing the outcome of the intervention will be recorded.


Original Secondary Outcome: Same as current

Information By: Octapharma

Dates:
Date Received: August 7, 2014
Date Started: September 2014
Date Completion: March 2019
Last Updated: May 3, 2016
Last Verified: May 2016