Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00713648

Purpose

The trial is conducted in Asia, Europe and North America. The aim of this trial is to evaluate Recombinant FXIII treatment in patients with FXIII Inherited Deficiency. It is expected that Recombinant FXIII can be used as prevention of bleeding episodes

Condition	Intervention	Phase
Congenital FXIII Deficiency	Drug: recombinant factor XIII	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital FXIII Deficiency

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Rate (number per subject year) of bleeding episodes requiring treatment with a FXIII containing product during the rFXIII treatment period [ Time Frame: After the last patient has completed the trial period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects having a normal clot solubility one hour after rFXIII administration and 28 days after rFXIII administration [ Time Frame: After the last patient has completed the trial period ] [ Designated as safety issue: No ]
Level of FXIII activity one hour after rFXIII administration and 28 days after rFXIII administration [ Time Frame: After the last patient has completed the trial period ] [ Designated as safety issue: No ]
Number of subjects with rFXIII antibody development [ Time Frame: After the last patient has completed the trial period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: recombinant factor XIII 35 IU/kg body weight, i.v. administration, once every 4 weeks

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Congenital FXIII A-Subunit deficiency
If on regular replacement therapy, then at least one treatment-requiring bleeding episode followed by at least 6 months' treatment, or a documented family history of Congenital FXIII A-Subunit deficiency
If on on-demand treatment, then at least two treatment-requiring bleeding episodes within last 12 months

Exclusion Criteria:

Known neutralizing antibodies (inhibitors) towards FXIII
Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
Documented history of 2 or more treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products
Known or suspected allergy to trial product(s) or related products
Planned major surgery during the trial period
Renal insufficiency defined as current dialysis therapy
Any history of confirmed venous or arterial thrombo-embolic events

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713648

Contacts

Contact: Novo Nordisk Clinical Trial Call Center

866-867-7178

Show 22 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Gita Ohlsson, MSc, PhD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F13CD-1725, EudraCT No: 2006-003148-51
Study First Received:	July 7, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00713648
Health Authority:	United States: Institutional Review Board; Austria: Agency for Health and Food Safety; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; Switzerland: Federal Office of Public Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; Canada: Health Canada; Finland: National Agency for Medicines

Study placed in the following topic categories:

Hemorrhage

ClinicalTrials.gov processed this record on January 14, 2009