TachoSil Paediatric Liver Trial (TC-019-IN)

May 4, 2012 updated by: Nycomed

A Prospective, Multi-centre Phase III-b Study of TachoSil in Paediatric Patients Scheduled for Resection of the Liver With or Without Segmental Liver Transplantation.

The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.

Study Overview

Status

Completed

Conditions

Liver Diseases

Intervention / Treatment

Drug: Fibrinogen human (TachoSil)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Roskilde, Denmark, 4000
    - Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 6 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities?
Is the child above 4 weeks and below 6 years of age?
Has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or Has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed?
Is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?

All inclusion criteria must be answered "yes" for a child to participate in the study.

Exclusion criteria:

Was the child retransplanted or had liver transplantation in combination with other organs?
Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease?
Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
Has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - Antitrypsin?
Did the child undergo an emergency operation?
Does the child participate in another clinical trial during the intra-operative phase?
Has any serious surgical complication occurred?
Has any fibrin glue haemostatic (including TachoSil ® ) been used on the target wound before the planned application of TachoSil ® ? To participate in the study all exclusion criteria must be answered "No" for a child having segmental resection. For a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "Yes".

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective is to collect data on efficacy, i.e. intra-operative haemostasis, and safety of TachoSil ® as treatment to control local bleeding in children undergoing surgical resection of the liver with or without segmental transplantation. Time Frame: 7½ months	7½ months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Investigators

Study Chair: Clinical Trial Operations, Headquaters

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria