EUCTR2011-004154-25-BG进行中（未招募）1 期
A prospective, open-label, phase I/III study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 36
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. Known congenital afibrinogenemia or severe congenital hypofibrinogenemia
- •2. Plasma fibrinogen activity = 0.5 g/l and antigen = 0.5 g/l
- •3. Male or female
- •4. Age 0 to 75 years, with the first ten patients will be 18 years or older
- •5. Presumed to be compliant with the study procedures and to terminate the study as scheduled
- •6. Willing and able to be hospitalized for 3 days for the pharmaco-kinetic assessment (if applicable)
- •7. Willing and able to be hospitalized - if required - in case of interventions (e.g., surgical procedures, major bleeds)
- •8. Written informed consent by the patient, his/her parents or by the patient's legal / authorized representative as applicable
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •General exclusion criteria:
- •1. Known congenital dysfibrinogenemia
- •2. Known bleeding disorder other than congenital fibrinogen deficiency
- •3. History of esophageal variceal bleeding
- •4. Known presence or history of venous/arterial thrombosis or thromboembolic event (TEE) in the preceding 6 months
- •5. Known presence or history of fibrinogen inhibitory antibodies
- •6. Known presence or history of hypersensitivity to human fibrinogen or human plasma proteins e.g., immunoglobulins, vaccines or hypersensitivity to any of the excipients
- •7. Known positive serology for HIV-1 and HIV-2
- •8. Clinically relevant biochemical or hematological findings (except due to underlying disease or emergency bleeding) outside the normal range (at the investigator's discretion)
- •9. Clinically relevant pathological findings in physical examination including electrocardiogram (ECG)
- •10. Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 2 weeks prior to infusion of BT524
- •11. Concomitant medication interacting relevantly with the coagulation system (e.g., low molecular weight heparin, unfractioned heparin, factor Xa inhibitors, factor IIa inhibitors or PY12 inhibitors) within 2 weeks prior to infusion of BT524
- •12. Recent vaccination within 3 weeks prior to infusion*
- •13. Body weight (BW) below 22 kg for patients = 6 years*; BW below the 5th percentile of the normal range for children **
- •14. End stage disease
- •15. Abuse of drugs
- •16. Unable to understand and follow the study requirements (refers to the patient, his/her parents or to the patient's legal / authorized representative as applicable)
- •17. Participation in another interventional clinical study within 30 days before entering the study or during the study
- •18. Pregnant/ nursing woman, or woman of childbearing potential not using reliable/ effective contraceptive method(s) during the study and at least one month after the last administration of study drug (e.g., oral/ injectable/ implantable/ insertable/ topical hormonal contraceptives, intrauterine devices, female sterilization, partner's vasectomy or condoms)
- •19. Any other condition that, to the investigator's judgment, could have an impact on patient's safety or the study results
- •* only applicable for patients in PK part I
- •** refers to local standards
- •PK-specific exclusion criteria:
- •20. Elective surgery during the 14 day PK blood sampling period
- •21. Acute infection
- •22. Clinically relevant increase or decrease in body temperature
- •23. Actively bleeding or anticipated bleeding (including female menorrhea) at the time point of or within 7 days prior to infusion of BT524
- •24. Surgery within 7 days prior to infusion of BT524
- •25. Immobilization within 7 days prior to infusion of BT524
- •26. Intake of alcohol or significantly increased intake of caffeine containing products within 24 hours prior to infusion of BT524
- •27. Blood donation or comparable blood loss within 60 days prior to infusion of BT524
- •28. Excessive physical exercise (extreme sports activities, sauna) within 72 hours prior to infusion of BT524
研究者
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