EUCTR2015-005490-20-NO进行中（未招募）1 期
A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects with Hypoplasminogenemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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. Subject or legal guardian has provided informed consent (as well as assent by subjects with ages dictated by local Investigational Review Board (IRB) guidelines).
- •2. Subject is male or female between the ages of 2 and 80 years (inclusive).
- •3. Subject has a documented history of lesions and symptoms consistent with a diagnosis of hypoplasminogenemia.
- •4. Subject has plasminogen levels =< 45%.
- •5. Subject has documented vaccination to hepatitis A virus (HAV) and hepatitis B virus (HBV), or has received the first dose of HAV and HBV vaccine prior to the first dose of IMP and is scheduled to receive the second vaccine dose. If subject has documented vaccination more than 1 year before screening but has a negative antibody titer to HAV and/or HBV at screening, subject is required to begin a re-vaccination series with the first dose of HAV and/or HBV vaccine prior to the first dose of IMP and is scheduled to receive the second vaccine dose. No re-vaccination is required, if the documented vaccination took place within 1 year of screening.
- •6. Subject agrees to use contraceptive methods from screening through 14 days after last dose of study treatment (unless documented as biologically or surgically sterile (e.g. postmenopausal, vasectomized), or has not reached reproductive age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •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. Subject has a history of anaphylactic reactions to blood or blood products that may interfere with participation in the study in the opinion of the investigator.
- •2. Subject has uncontrolled hypertension.
- •3. Subject has clinical or laboratory evidence of an intercurrent infection as evidenced by symptoms including fever, tachycardia, or other systemic signs and symptoms. (Note: Subjects with an intercurrent clinically significant infection cannot participate; however, once the infection has resolved according to the investigator, they can be re-screened if enrollment is still open.)
- •4. Subject is pregnant and/or lactating.
- •5. Subject has a malignancy, except for basal or squamous cell skin cancer, within 3 years before screening.
- •6. Subject is a previous organ transplant recipient.
- •7. Subject is in receipt of exogenous plasminogen (ocular or IV), such as laboratory grade plasminogen, fresh frozen plasma, or ProMetic Plasminogen (Human) within 2 weeks of the first dose of the IMP.
- •8. Subject has a psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to provide informed consent or to comply with the requirements of the study protocol.
- •9. Subject has evidence of renal dysfunction defined as of > 2 x the upper limit of normal (ULN) in serum creatinine.
- •10. Subject has evidence of hepatic dysfunction defined as > 3 x ULN in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP).
- •11. Subject has participated in another IRB-approved interventional clinical trial of drug, biologic, or device within 30 days before the first dose of the IMP.
- •12. Subject has a chronic or acute clinically significant intercurrent illness (e.g., cardiac, hepatic, renal, endocrine, neurologic, hematologic, neoplastic, immunological, and skeletal) that the investigator determines could interfere with the assessments in this study.
研究者
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