EUCTR2006-003148-51-ES进行中（未招募）不适用
Ensayo multicéntrico, abierto, con un único brazo de tratamiento y dosis múltiple sobre la eficacia y seguridad de la terapia sustitutiva mensual con factor XIII recombinante (rFXIII) en sujetos con deficiencia congénita de factor XIIIVersión del Protocolo 2 (2008-02-06) y Enmienda relevante 1 versión 2 (2008-04-08). - F13CD-1725
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit).
- •3. Treatment with regular FXIII replacement therapy initiated at least 6 months prior to screening and one of the following : a documented history of =1 treatment-requiring bleeding episode prior to initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency (only for subjects on regular replacement therapy prior to screening).
- •4. Documented history of = 2 bleeding episodes requiring treatment with FXIII containing blood products within the last 12 months prior to screening (only for subjects receiving on-demand treatment prior to screening).
- •5. Subjects with age = 6 years and a weight =20 kg. Before enrolling subjects = 6 to < 12 years of age in the EU countries, 7 subjects have to be exposed for 12 weeks (3 exposures) to trial product with a safe safety profile.
- •6. If female and of child-bearing 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
排除标准
- •1. Known neutralizing antibodies (inhibitors) towards FXIII.
- •2. Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency.
- •3. Documented history of = 2 treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products (FFP, pd FXIII and cryoprecipitate).
- •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.
- •7. Subject has received treatment with any investigational drug within 30 days of trial enrolment, except pdFXIII.
- •8. Planned major surgery during the trial period. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject.
- •9. Renal insufficiency defined as current dialysis therapy.
- •10. Any history of confirmed venous or arterial thrombo-embolic events.
- •11. Subject has received any anti-thrombotic or anti-platelet drugs within 7 days of trial enrollment.
- •12. Subject has medical, social or psychosocial factors expected to impact compliance or safety.
- •13. 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.
- •14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in participating in the trial.
- •15. Females of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) from the time of enrollment to completion of all follow-up trial visits.
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