Peripheral arterial occlusive disease (PAOD), Chronic limb-threatening ischemia (CLTI)
Conditions
Brief summary
Part A: Occurrence and severity of treatment-emergent adverse events (TEAEs) from baseline to D29 (Part A1) and D90 (Part A2) after the first dose of APAC. Other safety and tolerability endpoints: • physical examination findings • vital signs • clinical laboratory data • bleeding events (International Society on Thrombosis and Haemostasis (ISTH) bleeding score, Part B: Occurrence and severity of TEAEs from baseline to D90 after the first dose of APAC Other safety and tolerability endpoints: • physical examination findings • vital signs • clinical laboratory data • bleeding events (ISTH bleeding score) • surgical AEs, collected according to the Clavien-Dindo classification
Detailed description
Part A: 1. Changes in the clinical status of PAOD a. Fontaine classification, b. Wound Ischemia foot Infection (WIfI) scoring, c. hemodynamics (toe-brachial blood pressure index [TBI] and ankle-brachial systolic blood pressure index [ABI]) at rest and in Part A2 patients also after treadmill exercise test, and d. in Part A2, maximal walking distance in a treadmill exercise test (3.2 km/h, 10% incline)., Part A: 2. Changes in PD and PK of selected biomarkers, Part A: 3. MALE and MACE-free survival and Quality of life (assessed using quality of life questionnaire EQ-5D-5L, ischemic pain using visual analog scale, and ischemic ulcers or gangrene and physical performance using tailored questionnaire)., Part B: 1. Changes in the clinical status of PAOD a. Fontaine classification, b. WIfI scoring, c. outcome of recanalization (hemodynamics; TBI and ABI) at rest., Part B: 2. Changes in PD and PK of selected biomarkers, Part B: 3. MALE and MACE-free survival and Quality of life (assessed using quality of life questionnaire EQ-5D-5L, ischemic pain using visual analog scale, ischemic ulcers or gangrene, and physical performance using tailored questionnaire).
Sponsors
Aplagon Oy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Occurrence and severity of treatment-emergent adverse events (TEAEs) from baseline to D29 (Part A1) and D90 (Part A2) after the first dose of APAC. Other safety and tolerability endpoints: • physical examination findings • vital signs • clinical laboratory data • bleeding events (International Society on Thrombosis and Haemostasis (ISTH) bleeding score, Part B: Occurrence and severity of TEAEs from baseline to D90 after the first dose of APAC Other safety and tolerability endpoints: • physical examination findings • vital signs • clinical laboratory data • bleeding events (ISTH bleeding score) • surgical AEs, collected according to the Clavien-Dindo classification | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: 1. Changes in the clinical status of PAOD a. Fontaine classification, b. Wound Ischemia foot Infection (WIfI) scoring, c. hemodynamics (toe-brachial blood pressure index [TBI] and ankle-brachial systolic blood pressure index [ABI]) at rest and in Part A2 patients also after treadmill exercise test, and d. in Part A2, maximal walking distance in a treadmill exercise test (3.2 km/h, 10% incline)., Part A: 2. Changes in PD and PK of selected biomarkers, Part A: 3. MALE and MACE-free survival and Quality of life (assessed using quality of life questionnaire EQ-5D-5L, ischemic pain using visual analog scale, and ischemic ulcers or gangrene and physical performance using tailored questionnaire)., Part B: 1. Changes in the clinical status of PAOD a. Fontaine classification, b. WIfI scoring, c. outcome of recanalization (hemodynamics; TBI and ABI) at rest., Part B: 2. Changes in PD and PK of selected biomarkers, Part B: 3. MALE and MACE-free survival and Quality of life (assessed usin | — |
Countries
Finland
Outcome results
None listed