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 ]
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