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Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

NCT ID: NCT00713648

Last Updated: 2017-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Congenital FXIII Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rFXIII

Group Type EXPERIMENTAL

catridecacog

Intervention Type DRUG

35 IU/kg body weight, i.v. administration, once every 4 weeks

Interventions

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catridecacog

35 IU/kg body weight, i.v. administration, once every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit)
* Treatment with regular FXIII replacement therapy initiated at least 6 months prior to screening and one of the following : a documented history of at least one 1 treatment-requiring bleeding episode prior to initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency (only for subjects on regular replacement therapy prior to screening)
* Documented history of at least two 2 bleeding episodes requiring treatment with FXIII containing blood products within the last 12 months prior to screening (only for subjects receiving on-demand treatment prior to screening)

Exclusion Criteria

* Known neutralizing antibodies (inhibitors) towards FXIII
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Documented history of at least 2 treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products (fresh frozen plasma (FFP), plasma-derived FXIII (pd FXIII) and cryoprecipitate)
* Known or suspected allergy to trial product(s) or related products
* Planned major surgery during the trial period. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
* Renal insufficiency defined as current dialysis therapy
* Any history of confirmed venous or arterial thrombo-embolic events
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Orange, California, United States

Site Status

Novo Nordisk Investigational Site

Tampa, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Detroit, Michigan, United States

Site Status

Novo Nordisk Investigational Site

East Lansing, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Columbus, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Seattle, Washington, United States

Site Status

Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Klagenfurt, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

Novo Nordisk Investigational Site

Marseille, , France

Site Status

Novo Nordisk Investigational Site

Montpellier, , France

Site Status

Novo Nordisk Investigational Site

Bonn, , Germany

Site Status

Novo Nordisk Investigational Site

Braunschweig, , Germany

Site Status

Novo Nordisk Investigational Site

Duisburg, , Germany

Site Status

Novo Nordisk Investigational Site

Petah Tikva, , Israel

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Vicenza, , Italy

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Birmingham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bradford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bristol, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Liverpool, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Austria Canada Finland France Germany Israel Italy Spain Switzerland United Kingdom

References

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Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26.

Reference Type RESULT
PMID: 22451421 (View on PubMed)

Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornoe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

Reference Type RESULT
PMID: 25643920 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-003148-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F13CD-1725

Identifier Type: -

Identifier Source: org_study_id

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