A clinical study to evaluate safety and efficacy of a new treatment in patients with tympanic membrane perforations
- Conditions
- Tympanic Membrane PerforationMedDRA version: 20.0Level: PTClassification code 10045210Term: Tympanic membrane perforationSystem Organ Class: 10013993 - Ear and labyrinth disordersTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2017-002927-68-SE
- Lead Sponsor
- Prometic Biotherapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method