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. - F13CD-3720

• Conditions: Factor XIII Congenital deficiency.; MedDRA version: 9.1Level: HLGTClassification code 10064477; MedDRA version: 9.1Level: HLTClassification code 10009737; MedDRA version: 9.1Level: PTClassification code 10016083

• Registration Number: EUCTR2008-007883-41-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-31
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). 2. Previous participation (means up to and inclusive Visit 16, (EOT)) in F13CD-1725. 3. If female and of childbearing potential: negative pregnancy test at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known neutralizing antibodies (inhibitors) towards FXIII. 2. Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency. 3. Documented history of ≥ 3 spontaneous and haemostatic treatment-requiring bleeding episodes per year during previous regular replacement therapy with rFXIII 4. Platelet count (thrombocytes) < 75 ? 10^9/L. 5. Known or suspected allergy to trial product(s) or related products. 6. Previous participation in this trial. (Defined as screened at visit 1). 7. Treatment with any investigational drug within 30 days of trial enrolment, except pdFXIII and rFXIII 8. Renal insufficiency defined as currently requiring dialysis therapy. 9. Any history of confirmed venous or arterial thrombo-embolic events, including myocardial infarction or stroke 10. Medical, social or psychosocial factors expected to impact compliance or safety. 11. Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome. 12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in participating in the trial. 13. Females of childbearing potential who are pregnant, breastfeeding or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) from the time of enrolment to completion of all follow-up trial visits, if there is any risk of pregnancy in the opinion of the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified