Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05372718
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 and older;
* Diagnosis of I-II b degree of ALI;
* Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
* women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
* men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility);
* Availability of signed and dated informed consent of the patient to participate in the study.
Exclusion Criteria:
* Extensive bleeding at present;
* Intracranial (including subarachnoid) hemorrhage at present;
* Recent gastrointestinal bleeding (within 10 days);
* Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
* Systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110 mm Hg or the need for intravenous drugs to lower blood pressure to these limits;
* Pregnancy, lactation;
* Known hypersensitivity to Fortelyzin®;
* Platelet count less than 100,000/µL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05372718
Study Brief:
Protocol Section:
NCT05372718