EUCTR2011-004154-25-DE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
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, known hypodysfibrinogenemia*
- •(*only applicable in adult patients in part II)
- •2. Plasma fibrinogen activity = 0.5 g/l and antigen = 0.5 g/l
- •(not applicable for adult patients with hypodysfibrinogenemia).
- •3. Male or female
- •4. Age 6 to 75 years, with the first ten patients and patients with hypodysfibrinogenemia 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
- •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 (not applicable for adult patients with hypodysfibrinogenemia in study part II)
- •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 in the preceding 6 months or family history of thrombophilia in adult patients with hypodysfibrinogenemia
- •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 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 (e.g. diabetes mellitus or liver function disorders in adult patients with hypodysfibrinogenemia)
- •* 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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