EUCTR2011-004154-25-IT进行中（未招募）1 期
A prospective, open-label, phase I/II 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
- 20
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.Congenital afibrinogenemia or severe congenital hypofibrinogenemia defined by plasma fibrinogen activity = 0.5 g/l and antigen = 0.5 g/l
- •2.Male or female
- •3.Age 6 to 75 years, with the first ten patients will be 18 years or older
- •4.Presumed to be compliant with the study procedures and to terminate the study as scheduled
- •5.Willing and able to be hospitalized for 3 days for the pharmaco-kinetic assessment
- •6.Willing and able to be hospitalized - if required - in case of interventions (e.g., surgical procedures, major bleeds)
- •7.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: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
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 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
- •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 (at least 3 weeks)
- •13.Body weight below 22 kg
- •14.End stage disease
- •15.Abuse of drugs
- •16.Unable to understand and follow the study requirements
- •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
- •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
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