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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-016869-28-GB |
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Date of registration:
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07/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency
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Scientific title:
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A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency |
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Date of first enrolment:
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20/09/2010 |
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Target sample size:
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6 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016869-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Single intravenous dose
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Signed Informed Consent by subject’s parents or subject’s legally acceptable representative before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
2. Age 1 to less than 6 years old at the time of enrolment
3. Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
4. Body weight = 10 kg
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Received blood products or FXIII concentrates within 4 weeks of trial product administration
2. Known antibodies to FXIII
3. Previous participation in this trial. Participation is defined as dosed and withdrawn
4. Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
5. Platelet count (thrombocytes) < 50 × 10 9/L (at screening visit)
6. Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
7. Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
8. Administration of any antithrombotic or antiplatelet drugs within 7 days of trial enrolment
9. Known or suspected allergy to trial product or related products
10. Received treatment with any experimental agent within 30 days of trial enrolment
11. Any concurrent serious chronic or acute illness or infection expected to impact compliance or safety as judged by the investigator
12. Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
13. Medical, social, or psychosocial factors expected to impact compliance or safety
14. Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Congenital FXIII A-subunit Deficiency
MedDRA version: 13.1
Level: PT
Classification code 10016083
Term: Factor XIII deficiency
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Product Name: Recombinant factor XIII (rFXIII)
Product Code: NN 1841
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Current Sponsor code: NN1841
Other descriptive name: Recombinant factor XIII (rFXIII)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
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Primary Outcome(s)
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Primary end point(s): Area under the concentration vs. time curve (AUC 0-30 Days) (IU×h/mL)
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Main Objective: To characterise the pharmacokinetics of rFXIII in paediatric subjects (1 to less than 6 years old) with congenital FXIII A-subunit deficiency following a single intravenous dose administration by measuring the area under the concentration vs. time curve (AUC0-30 Days) (IU×h/mL)
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Secondary Objective: • To investigate additional Pharmacokinetic (PK) parameters
• To evaluate the safety of a single intravenous dose of rFXIII in paediatric subjects (1 to less than 6 years old) with congenital FXIII A-subunit deficiency
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Secondary ID(s)
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F13CD-3760 (mentor™4)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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