CSL511_3003

• Research type

  Research Study

• Full title

  A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects with Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

• IRAS ID

  1010044

• Contact name

  Ewa Szczepańska

• Contact email

  Ewa.szczepanska@cslbehring.com

• Sponsor organisation

  CSL Behring

• Eudract number

  2016-003749-27

• Research summary

  The aim of the study is to assess the efficacy and safety of CSL511 (fibrinogen {a plasma protein that plays a key role in blood clotting } concentrate human ) in establishing hemostasis (process of stopping bleeding, typically through vasoconstriction, formation of a platelet plug and blood clotting) in subjects with acquired fibrinogen deficiency undergoing cytoreductive surgery (CRS) with hyperthermic intrapertoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP). The main objectives of this study is to compare the overall hemostatic efficacy (intraoperative and post operative ) of CSL511 and cyroprecipitate in bleeding subjects undergoing CRS with HIPEC for PMP.
  The study is a phase 3, prospective, single center, randomized, open label , controlled, parallel-arm, interventional study to assess the efficacy and safety of CSL511 in subjects undergoing CRS with HIPEC for PMP with predicted intraoperative blood loss of > 2L. Eligible subjects will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cytorprecipitate. Study will be conducted at one site in the United Kingdom. Study duration for an individual subject will be approximately 60 days. Overall study duration is expected to be approximately 24 months. A total of 90 are estimate to be enrolled to ensure 82 subjects are evaluable for the primary endpoint. A subject is considered enrolled in the study when they or their legally acceptable representative, has agreed to participate in the clinical study after completing the informed consent process and the screening/eligibility period. Potential subjects who are screened but fail the screening/ eligibility period or who do not meet all eligibility criteria, are not considered enrolled.

• REC name

  Wales REC 5

• REC reference

  24/WA/0144

• Date of REC Opinion

  19 Jun 2024

• REC opinion

  Further Information Favourable Opinion