EUCTR2017-002927-68-SE进行中（未招募）1 期
A Phase 1/2A, Dose Escalation, Randomized, Placebo Controlled Study of the Safety, Feasibility, and Efficacy of Subcutaneous Plasminogen (Human) 10 for the Treatment of Chronic Tympanic Membrane Perforation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
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 aged 18-70 years (both inclusive)
- •2) Subject has signed informed consent
- •3) Diagnosed with dry TMP that has been present for at least 6 months
- •4) TMP occupies 15-30% (both inclusive) of the surface area of the tympanic membrane at screening; if a subject has a TMP in both ears that meets all inclusion criteria, then the TMP associated with the worst hearing will be included in the study
- •5) Female subjects of childbearing potential must have a negative urine pregnancy test at screening. Female subjects of childbearing potential who are sexually active with a non sterile male partner must agree to use adequate birth control from the time of screening until 4 weeks after the last study drug administration.
- •If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method from the time of screening until 4 weeks after the last study drug administration.
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1) History of hypersensitivity reaction to blood products, plasma-derived products, local anesthesia, or aprotinin
- •2) Treatment with exogenous plasminogen (such as fresh frozen plasma) or a fibrinolytic agent (such as recombinant tissue plasminogen activator or streptokinase) during the 2 weeks prior to screening
- •3) Treatment with anti-inflammatory agents (including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]), immunosuppressive drugs (including any form of steroids or chemotherapy), growth factors, or anti-fibrinolytics (tranexamic acid, epsilon aminocaproic acid, or aprotinin) during the 2 weeks prior to screening
- •4) Treatment of any infection with systemic antimicrobial agents (antibiotics, antivirals, antifungals) during the 2 weeks prior to screening
- •5) Sensorineural hearing loss (SNHL) >35 dB in the affected ear, measured no more than 14 days before first dose of study drug
- •6) Recurrent or chronic bacterial infection in the affected ear during the 4 weeks prior to screening
- •7) Prior middle ear surgery in the affected ear (except tympanostomy)
- •8) History of malignancy treated in past 3 years (except for basal or squamous cell skin cancer)
- •9) Creatinine >2x the upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3x ULN
- •10) History of diabetes
- •11) History of immunodeficiency disease
- •12) Other significant medical condition that the Investigator determines could interfere with compliance or study assessments (such as: recurrent or chronic infection, dementia, substance abuse, serious or unstable chronic organ disease)
- •13) If female: pregnant or lactating
- •14) Has participated in another investigational drug or medical device study for any medical condition during the 4 weeks prior to screening
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