EUCTR2013-004343-23-IT进行中（未招募）1 期
Studio per indagare le proprietà farmacocinetiche (per vedere quanto è attivo il farmaco di studio nel sangue e quanto tempo ci vuole per il farmaco di studio per uscire dal sangue), l'efficacia e la sicurezza di FIB Grifols in soggetti con carenza congenita di fibrinogeno - IG0902
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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 Male or female subjects less than 70 years old.
- •2 Sign the written Informed Consent Form (ICF), or the subject's parent
- •or legal guardian signs 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 Subjects diagnosed with congenital fibrinogen deficiency manifested
- •as afibrinogenemia.
- •4 Subjects with a fibrinogen level undetectable, or equal or less than 30
- •mg/dL determined by both Clauss and antigen methods at baseline.
- •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
- •6 Female subjects of child-bearing potential and their partners have
- •agreed to practice contraception using a method of proven reliability
- •(i.e. hormonal methods, barrier methods, intrauterine devices methods,
- •or abstinence) to prevent a pregnancy during the course of the clinical
- •7 Subjects must be willing to comply with all aspects of the clinical trial
- •protocol, including blood sampling, for the whole duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1 Subjects who received any fibrinogen-containing product within 21
- •days prior to Day 0 Visit.
- •2 Subjects who present with active bleeding within 10 days prior to
- •infusion on Day 0.
- •3 Subjects with acquired (secondary) fibrinogen deficiency.
- •4 Subjects diagnosed with dysfibrinogenemia.
- •5 Subjects with documented history of deep vein thrombosis (DVT),
- •pulmonary embolism, or arterial thrombosis within
- •1 year prior to enrolment in this clinical trial.
- •6 Subjects with known antibodies against fibrinogen.
- •7 Subjects with a history of severe anaphylactic reactions or reactions
- •to any blood-derived product.
- •8 Subjects with a history of intolerance to any component of the
- •investigational product.
- •9 Subjects with a documented history of IgA deficiency and antibodies
- •against IgA.
- •10 Females who are pregnant or breastfeeding.
- •11 Subjects with renal impairment (i.e. serum creatinine exceeds more
- •than 2.0 times the upper limit of normal [ULN]) at baseline.
- •12 Subjects with aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) levels exceeding more than 2.5 times the ULN at
- •13 Subjects with a history of chronic alcoholism or illicit drug addiction
- •in the preceding 12 months prior to enrollment in this clinical trial.
- •14 Subjects with any medical condition which is likely to interfere with
- •the evaluation of the study drug and/or the satisfactory conduct of the
- •clinical trial according to the investigator's judgment.
- •15 Subjects who received aspirin-containing products and nonsteroidal
- •anti-inflammatory drugs (NSAIDs) within 7 days prior to the Day 0 Visit.
- •16 Subjects currently receiving, or having received within 3 months
- •prior to enrolment into this clinical trial, any investigational drug or
- •17 Subjects who were previously administered the investigational
- •product FIB Grifols during this clinical trial (i.e. every subject can only
- •participate in the study once).
- •18 Subjects who are unlikely to adhere to the protocol requirements,
- •are likely to be uncooperative, or are unable to provide a storage serum
- •sample prior to investigational drug infusion.
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