EUCTR2019-001693-28-DE进行中（未招募）1 期
Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with congenital C1-INH deficiency and hereditary angioedema - CONE-01
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. Documented congenital C1-INH deficiency with C1-INH functional activity less than 50% and C4 level below the laboratory reference range.
- •2. Age =18 years at informed consent date.
- •3. Signed informed consent.
- •4. Patient must be capable to understand and comply with the relevant aspects of the study protocol.
- •5. Women of childbearing potential must have a negative pregnancy test at screening as well as pre-infusion and must agree to use acceptable methods of contraception from screening until final visit.
- •6. Fertile male patients must agree to use acceptable methods of contraception from screening until final visit.
- •Are the trial subjects under 18? no
- •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 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Any signs of an HAE attack OR HAE attack within 7 days prior to dosing with the IMP (OCTA-C1-INH) OR more than a total of 9 HAE attacks over the previous 3 months prior to dosing with the IMP.
- •2. Patients who have received prophylactic or acute treatment with C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin pathway inhibitors (e.g., ecallantide, icatibant), or treatment with tranexamic acid within 2 weeks prior to dosing with the IMP.
- •3. Patients who have received treatment with lanadelumab within 11 weeks prior to dosing with the IMP.
- •4. Patients with planned dental, medical, or surgical procedures who will need pre-procedural HAE prophylaxis during the study period.
- •5. Female patients taking estrogen-containing contraceptive regimen, hormone replacement therapy (excepting progesterone-only contraceptives, which are permitted), or selective estrogen receptor modulators (e.g., tamoxifen). Male patients on specific androgen therapy (e.g., testosterone, danazol, dehydroepiandrosterone/androstenedione).
- •6. Any change (start, stop, or change in dose) in androgen therapy (e.g., oxandrolone, stanozolol) in the last 14 days prior to dosing with the IMP.
- •7. Participated in any other investigational drug evaluation or received blood or a blood product, except for C1-INH, within 30 days prior to dosing with the IMP.
- •8. Live viral vaccination within 30 days prior to screening.
- •9. Acute infectious illness characterized by rapid onset of disease, a relatively brief period of symptoms, and resolution within a short period of time.
- •10. Risk factors for thromboembolic events, including presence of indwelling venous catheter or access device, history of thrombosis, underlying atherosclerosis, morbid obesity (defined as BMI of =35 kg/m2 and experiencing obesity-related health conditions or =40 to 44.9 kg/m2), immobility, or medications known to increase thromboembolic risk.
- •11. History of allergic reaction to C1-INH products or other blood products.
- •12. History of clinically relevant antibody development against C1-INH.
- •13. Any history of B-cell malignancy that was unresolved in the past 5 years.
- •14. Pregnancy or lactation.
- •15. Any clinically significant medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the patient’s ability to participate in the study.
研究者
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