CTRI/2021/03/032040尚未招募3 期
A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemia and severe hypofibrinogenemia requiring either on demand treatment for acute bleeding or surgical prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- 1.Hemostatic efficacy of FIB Grifols in on-demand treatment of all documented acute bleeding episodes as assessed by the Independent Endpoint Adjudication Committee (IEAC) Using a 4-Point Scale
研究概览
简要总结
This is a phase 3, multi-center, prospective,open-label, single-arm, clinical trial to be carried out in subjects withcongenital fibrinogen deficiency manifested as afibrinogenemia or severehypofibrinogenemia.
This clinical trial is planned to be performedat study sites in multiple countries. It is planned to include a maximum of 32adult and pediatric subjects with congenital fibrinogen deficiency in order toprovide at least 28 evaluable acute bleeding episodes and/or surgical procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male or female subject between 6 to 70 years of age 2 Signed and dated written ICF, or the subjects parent or legal guardian signs and dates the ICF where applicable, and the Subject Authorization Form SAF where applicable, Pediatric subjects, as defined by local regulations, will be asked to sign an age appropriate assent form 3 Diagnosed with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia (fibrinogen <50 mg/dL) and expected to require treatment for acute bleeding (either spontaneous or after trauma [defined as any accidental event leading to acute bleeding], or prophylaxis of bleeding before a surgical intervention or invasive procedure 4 Fibrinogen level < 50 mg/dL determined by Clauss method at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit) 5 Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit) 6 Willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the entire duration of the study.
排除标准
- •1 Has acquired (secondary) fibrinogen deficiency 2 Diagnosed with dysfibrinogenemia 3 Has known antibodies against fibrinogen 4 Has history of anaphylaxis or severe systemic response to any drug or blood-derived product 5 Has history of intolerance to any component of the IP 6 Documented history of immunoglobulin A (IgA) deficiency and antibodies against IgA 7 Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (eg, oral, injectable, or implantable hormonal methods of contraception, placement of an IUD or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinancea) throughout the study 8 Has any medical condition which is likely to interfere with the evaluation of the IP and/or the satisfactory conduct of the clinical trial according to the investigators judgment 9 Has congenital or acquired bleeding disorders other than congenital fibrinogen deficiency 10 Has life expectancy of less than 6 months 11 Received FRT within 21 days prior to the Screening Visit 12 Receiving, or having received within 3 months prior to the Screening Visit of this clinical trial, any investigational drug or device 13 Is unlikely to adhere the protocol requirements, or is likely to be uncooperative, or unable to provide a storage sample prior to IP infusion.
结局指标
主要结局
1.Hemostatic efficacy of FIB Grifols in on-demand treatment of all documented acute bleeding episodes as assessed by the Independent Endpoint Adjudication Committee (IEAC) Using a 4-Point Scale
时间窗: 1.Up to Day 7 | 2.Up to Day 7
2.Hemostatic efficacy of FIB Grifols in perioperative management of bleeding during and after all documented surgical procedures as assessed by the IEAC Using a 4-Point Scale
时间窗: 1.Up to Day 7 | 2.Up to Day 7
次要结局
- Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding Intra-operatively for All Surgical Procedures(Up to Day 7)
- Hemostatic Efficacy of FIB Grifols in Treating the First Documented Acute Bleeding Episode as Assessed by the IEAC Using a 4-Point Scale(Up to Day 7)
- Hemostatic Efficacy of FIB Grifols in Treating All Acute Bleeding Episodes(Up to Day 7)
- Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding During and After the First Documented Surgical Procedure as Assessed by the IEAC Using a 4-Point Scale(Up to Day 7)
- Hemostatic Efficacy of FIB Grifols in Treating the First Acute Bleeding Episode(Up to Day 7)
- Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding After All Surgical Procedures (ie, Post-operative)(Up to Day 7)
研究者
研究点 (5)
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