A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis in the Netherlands - A phase 2 study to assess the efficacy and safety of Fibrocaps in the Netherlands.

• Conditions: Hepatic resection or soft tissue dissection; MedDRA version: 12.1Level: LLTClassification code 10042609Term: Surgery

• Registration Number: EUCTR2010-020202-16-NL
• Lead Sponsor: ProFibrix BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Inclusion Criteria (pre-surgery)
1.Male or female = 18 years of age
2.Subjects who are able and willing to provide written and signed informed consent
3.Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
4.Has a life expectancy of at least one year
Inclusion Criteria (during surgery)
5.Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical
6.Absence of intra-operative complications other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
7.No intra-operative use of a topical hemostat containing thrombin
8.Target Bleeding Site surface area of = 100 cm2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating women
2.Has a known intolerance to blood products or to Fibrocaps components
3.Unwilling to receive human blood products
4.Subject has a known allergy to porcine gelatin
5.Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
6.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 during the 4 weeks after surgery
7.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
8.Aspartate Aminotransferase or Alanine aminotransferase (AST/ASAT or ALT/ALAT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection where there is no upper limit for these analytes due to the nature of their disease
9.Platelets < 100 x10E9 PLT/L during screening
10.aPTT > 100 seconds during screening
11.INR > 2.5 during screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified