Phase 3 Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01527357
First received: January 26, 2012
Last updated: June 6, 2014
Last verified: June 2014

January 26, 2012
June 6, 2014
May 2012
April 2013   (final data collection date for primary outcome measure)
Time to Hemostasis (TTH) [ Time Frame: Within 5 minutes of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01527357 on ClinicalTrials.gov Archive Site
  • Incidence, severity and relationship of Adverse Events [ Time Frame: During 4 wks post-treatment ] [ Designated as safety issue: Yes ]
  • Incidence of Hemostasis [ Time Frame: 3 and 5 minutes post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 3 Study of Fibrocaps™ in Surgical Bleeding
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.

This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the European Union and United States.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Mild or Moderate Surgical Bleeding
  • Biological: Fibrocaps (PRO-0601)
    Human fibrinogen and thrombin powder Single application during surgery
    Other Names:
    • PRO-0601
    • Fibrin sealant
  • Device: Gelatin sponge
    Single application during surgery
    Other Name: Gelfoam, Spongostan
  • Experimental: Fibrocaps (PRO-0601)
    Fibrocaps (PRO-0601) powder plus gelatin sponge
    Interventions:
    • Biological: Fibrocaps (PRO-0601)
    • Device: Gelatin sponge
  • Active Comparator: Gelatin sponge
    Gelatin sponge (e.g., Gelfoam, Spongostan)
    Intervention: Device: Gelatin sponge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
719
June 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
  2. Subject is undergoing one of the 4 surgical procedures described
  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
  6. Subject has not received blood transfusion between screening and study treatment
  7. Presence of mild to moderate surgical bleeding
  8. Absence of intra-operative complications
  9. No intra-operative use of a topical hemostat containing thrombin prior to study treatment
  10. Approximate bleeding site surface area of less than or equal to 100 cm2

Exclusion Criteria:

  1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  3. Subject has known allergy to porcine gelatin
  4. Subject is unwilling to receive blood products
  5. 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 INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
  6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
  7. Platelets < 100 x109 PLT/L during screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Netherlands,   United States,   Belgium
 
NCT01527357
FC-004
Yes
ProFibrix, Inc.
ProFibrix, Inc.
Not Provided
Study Director: Paul Frohna, MD, PhD ProFibrix, Inc.
Principal Investigator: Robert J Porte, MD, PhD University Medical Centre Groningen
ProFibrix, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP