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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01253811
Other study ID # F13CD-3835
Secondary ID U1111-1117-10632
Status Completed
Phase Phase 3
First received December 1, 2010
Last updated April 7, 2015
Start date January 2011
Est. completion date March 2015

Study information

Verified date April 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial will be conducted in Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentorâ„¢4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria:

- Completed participation in trial F13CD-3760 (NCT01230021)

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product or related products

- Known history of development of inhibitors against FXIII (factor XIII)

- Hereditary or acquired coagulation disorder other than FXIII congenital deficiency

- Platelet count (thrombocytes) less than 50X10e9 / L

- Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus

- Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis

- Any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
catridecacog
Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week

Locations

Country Name City State
United States Novo Nordisk Clinical Trial Call Center Columbus Ohio
United States Novo Nordisk Clinical Trial Call Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Israel,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment emergent (serious and non-serious) adverse events every 4th week, from 0 to week 56 No
Secondary Frequency of development of anti-rFXIII antibodies, including inhibitors every 4th week, from week 0 to week 56 No
Secondary Clinical laboratory assessments: Biochemistry, haematology every 6th month, from 0 to week 56 No
Secondary Physical examinations every 4th week, from 0 to week 52 No
Secondary Vital signs (Blood Pressure) every 4th week, from week 0 to week 56 No
Secondary Vital signs (Pulse) every 4th week, from week 0 to week 56 No
Secondary Rate (number per subject year) of all bleeding episodes requiring treatment with a FXIII containing product other than recombinant factor XIII weeks 0-52 No
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Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3