A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.

Study Overview

• Status: Completed
• Conditions: Surgical Bleeding
• Intervention / Treatment: Drug: Fibrocaps; Drug: TachoSil

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Universitaetsklinik Innsbruck
  • Linz, Austria, A-4010
    • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
  • Wien, Austria, A-1090
    • Medizinische Universitaet Wien AKH
• Germany
  • Aachen, Germany, 52074
    • Universitaetsklinikum Aachen, RWTH
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum
  • Frankfurt am Main, Germany, D-60488
    • Krankenhaus Nordwest Gmbh
  • Frankfurt am Main, Germany, D-60590
    • J. W. Goethe Universitaetsklinik Frankfurt
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig AoeR
  • Muenchen, Germany, 81377
    • Klinikum der LMU Muenchen - Campus Grosshadern
  • Munich, Germany
    • Klinikum Rechts der Isar Munich
  • Stuttgart, Germany
    • Klinikum Stuttgart - Katharinenhospital (KH)
  • Tuebingen, Germany, 72976
    • Universitaetsklinikum Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (pre-surgery):

1. Subject has signed an independent ethics committee (IEC)-approved informed consent document
2. Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines
3. Subject age is >18 years at time of consent
4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding

5. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

   Inclusion Criteria (during surgery):

6. Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
7. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
8. Approximate TBS surface area of ≤ 100 cm^2

Exclusion Criteria:

1. Subject has known hypersensitivity to Fibrocaps or any of its components
2. Subject has known allergy to porcine gelatin
3. Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
4. Subject is unwilling to receive blood products
5. Subject is having hepatic surgery due to emergency-traumatic event
6. Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections
7. Subject has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator, or baseline abnormalities of international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
8. Subject has a platelet count < 100 x10^9 PLT/L during screening
9. Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
10. Subject is currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 6 weeks after surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fibrocaps; Human fibrinogen and thrombin powder. Single application during surgery Other Names: Raplixa; PRO-0601; Fibrin sealant Device: Gelatin sponge. Single application during surgery Other Name: Spongostan	Drug: Fibrocaps; Other Names: Raplixa
ACTIVE_COMPARATOR: TachoSil; Human fibrinogen and thrombin powder. Single application during surgery	Drug: TachoSil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Hemostasis (TTH)	Within 5 minutes of treatment

Collaborators and Investigators

• Sponsor: Mallinckrodt
• Investigators: Principal Investigator: Wolf Bechstein, MD, J.W.Goethe-Universität

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (ESTIMATE): November 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FC-005; 2014-000816-32 (EUDRACT_NUMBER)