TachoSil Paediatric Liver Trial (TC-019-IN) | NCT00365248

Studies
TachoSil Paediatric Liver Trial (TC-019-IN)

NCT00365248

Sponsor

Nycomed

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

16Actual

Phase

Phase 3

Conditions

Liver Diseases

Interventions

Fibrinogen human (TachoSil)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-005028-42

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Aug 16, 2006

First Submission Date that Met QC Criteria

Aug 16, 2006

First Posted Date

Aug 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Name	Type	Description	Arm Group Labels	Other Names
Fibrinogen human (TachoSil)	Drug	Resection of the liver with or without segmental liver transplantation

Measure	Description	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.		7½ months

Eligibility Module

Eligibility Criteria

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".

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000209	Acute-Phase Proteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins