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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00978380 |
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Date of registration:
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15/09/2009 |
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Primary sponsor: |
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Public title:
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Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
mentor™2 |
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Scientific title:
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A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00978380 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Austria
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Canada
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Finland
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France
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Germany
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Israel
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Italy
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Japan
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Novo Nordisk Clinical Trial Call Center |
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Address:
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Telephone:
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866-867-7178 |
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Email:
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Affiliation:
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Name:
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Gita Ohlsson, M.Sc. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For subjects who participated in F13CD-1725:
- Previous participation (means up to and inclusive Visit 16, (End of Trial)) in
F13CD-1725
- For all other subjects:
- Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at
screening visit or documented results from previously performed genotyping)
- Body weight at least 20 kg
Exclusion Criteria:
- Known neutralizing antibodies (inhibitors) towards FXIII
- Any known congenital or acquired coagulation disorder other than congenital FXIII
deficiency
- Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated
in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.
- Females of childbearing potential who are pregnant, breastfeeding or are not using
adequate contraceptive methods
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Congenital Bleeding Disorder
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Congenital FXIII Deficiency
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Intervention(s)
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Drug: recombinant factor XIII
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Primary Outcome(s)
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Adverse Events (serious and non-serious)
[Time Frame: from week 0 to week 52]
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Secondary Outcome(s)
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Antibody and inhibitor development
[Time Frame: from week 0 to week 52]
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Secondary ID(s)
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2008-007883-41
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F13CD-3720
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JapicCTI-121958
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U1111-1111-9289
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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