A Phase 2 interventional study of APAC - dose level 0.50 mg/kg, and Unfractionated heparin (UFH) in Peripheral Arterial Occlusive Disease and Chronic Limb-Threatening Ischemia, sponsored by Aplagon Oy. Recruiting at 3 sites in Finland. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Aplagon Oy · Phase 2, Interventional, and Treatment
The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant [APAC]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed arteries in their legs (peripheral arterial occlusive disease [PAOD]), and in patients with severely restricted poor blood flow to the legs that threatens limb health (chronic limb-threatening ischemia [CTLI]). The study also aims to find the best dose of the medicine. The study consists of two parts: Part A will include patients with PAOD and CTLI, Part B will only include patients with CTLI who are having a procedure to restore blood flow in their legs. Both parts will be subdivided into two subgroups (A1 and A2, B1 and B2) which will test different APAC doses and compare single dosing to weekly dosing for 4 weeks. APAC is injected into the blood. The possible treatment response will be compared either to a placebo (a look-alike substance that contains no drug), or to the current standard treatment. Patients will participate in the study for up to 90 or 180 days. During this time, patients will be regularly examined and asked to answer questions concerning their quality of life.
Peripheral arterial occlusive disease is a group of vascular disorders characterized by narrowing and occlusion of peripheral arteries, often resulting in gradual reduction of the blood supply to the limbs. The main pathogenic mechanism of PAOD stems from atherosclerosis, thrombo-inflammation and thrombosis (atherothrombosis). Patients with PAOD are at increased risk of major adverse limb events (MALE, defined as above ankle amputation of the index limb or major reintervention) and major adverse cardiovascular events (MACE). The most severe form of PAOD, CTLI, is characterized by severely decreased blood flow to the lower limbs.
This Phase 2a open-label study will evaluate the safety, tolerability, and dosing regimen of the heparin proteoglycan mimetic APAC in patients with PAOD with moderate claudication (Fontaine stage IIa and IIb) and in patients with CLTI (Fontaine stage III and IV) undergoing endovascular revascularization.
The study consists of two parts (Part A and Part B), both with two subparts:
Part A will evaluate APAC in the PAOD/CLTI patient population. The primary objective is to evaluate safety and tolerability of i.v. APAC for single infusion (Part A1) and weekly dosing (Part A2). Secondary objectives include evaluation of the effects of APAC on the clinical status of PAOD, and assessment of pharmacokinetic (PK), pharmacodynamic (PD) and other blood coagulation parameters. In Part A1, patients are randomized (2:1) to APAC and control groups. In Part A2, patients are randomized (2:2:1) to two APAC dose levels and control. In Part A, safety and recommended dose(s) of APAC for Part B are studied. A Safety Review Committee (SRC) will evaluate the Part A1 and Part A2 data after all patients in a group have completed the Day 8 or Day 29 visit, respectively, and decide the use of reserve doses, and recommend the dose(s) for the Part B.
Part B will evaluate APAC in CTLI patients undergoing endovascular revascularization. As primary objective, safety of the selected dose(s) and dosing frequency of periprocedural i.a. and weekly i.v. APAC administration will be evaluated. Secondary objectives aim to establish a dosing regimen (single vs. multiple dosing) and preliminary efficacy. Moreover, PK, PD and other blood coagulation parameters, as well as the effects of APAC on MALE and MACE-free survival and quality of life will be assessed as secondary objectives.
For both subparts (B1 and B2), patients will be randomized in 2:1 ratio to APAC and control groups. Part B1 with periprocedural dosing can start after the favorable SRC statement from Part A1. All other study parts (Part A1 [Day 8], Part A2 [Day 29], and Part B1 [Day 29]) need to be finalized before the start of Part B2.
For all study patients, the duration of screening period is maximum 28 days. Safety and clinical measures will be collected until the end of the follow-up period (Part A1: Day 29, and Parts A2, B1, B2: Day 90). To assess the effects of APAC on clinical outcome and quality of life, study participants will be followed up for 90 days in Part A1 and 180 days in Part A2, Part B1, and Part B2 after the first dose of APAC. The study ends when the patient has completed the Day 90 (Part A1) and Day 180 (Part A2, B1, and B2) telephone survey to assess quality of life.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 42 is close to the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Aplagon Oy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Parts A1, B1 and B2):
Inclusion Criteria (Part A2):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: APAC - dose level 0.50 mg/kg,
Other: Unfractionated heparin (UFH)
Drug: APAC dose level 1: 0.25 mg/kg,
Drug: APAC dose level 2: 0.50 mg/kg,
Other: Vehicle (sterile saline, NaCL 0.9%)
Drug: APAC (single periprocedural dose)
Other: Unfractionated heparin (UFH)
Drug: APAC
Other: Unfractionated heparin (UFH)
single i.v. dosing
administered as standard of care
weekly i.v. dosing for 4 consecutive weeks
weekly i.v. dosing for 4 consecutive weeks
weekly i.v. dosing for 4 consecutive weeks
Dose is selected based on Part A data, periprocedural dosing.
Dose is selected based on Part A and Part B, periprocedural dosing plus dosing for 4 consecutive weeks.
Primary endpoint - Part A: Occurrence and severity of treatment-emergent adverse events (TEAEs)
Time frame: From baseline to Day 29 (Part A1) and Day 90 (Part A2) after the first dose of APAC
Primary endpoint - Part B: Occurrence and severity of TEAEs
Time frame: From baseline to Day 90 after the first dose of APAC
Secondary endpoint 1 - Part A: Fontaine classification
No unit of measure
Time frame: Assessed at screening (Day -28 to Day -1), at Day 29, Day 60 (Part A2 only) and Day 90 (Part A2) after the first dose of APAC
Secondary endpoint 1 - Part A: Wound Ischemia foot Infection (WIfI) scoring
No unit of measure
Time frame: Assessed at screening (Day -28 to Day -1), at Day 8, Day 15 (Part A2 only), Day 22 (Part A2 only), Day 29, Day 60 (Part A2 only) and Day 90 (Part A2) after the first dose of APAC
Secondary endpoint 1 - Part A: Toe-brachial blood pressure index (TBI) and ankle-brachial systolic blood pressure index (ABI)
No unit of measure
Time frame: Assessed at screening (Day -28 to Day -1) at Day 29, Day 60 (Part A2 only) and Day 90 (Part A2) after the first dose of APAC
Secondary endpoint 1 - Part A2: Maximal walking distance in a treadmill exercise test
Unit of measure: meters
Time frame: Assessed at screening (Day -28 to Day -1), at Day 29, Day 60 and Day 90 after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK, and other blood coagulation biomarkers - clotting time, clot formation time and activated clotting time
Unit of measure: seconds
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part A2), Day 22 (only Part A2) and Day 29
Secondary endpoint 2 - Part A: Changes in PD and PK, and other blood coagulation biomarkers - Maximum clot firmness
Unit of measure: millimeter
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part A2), Day 22 (only Part A2) and Day 29
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - Activated partial thromboplastin time
Unit of measure: seconds
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 2, Day 8, Day 15 (only Part A2), Day 22 (only Part A2), Day 29, Day 60 (only Part A2) and Day 90 (only Part A2) after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - Anti-Factor IIa activity
Unit of measure: International Units per milliliter (IU/mL)
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part A2) and Day 22 (only Part A2) after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - Anti-Factor Xa activity
Unit of measure: International Units per milliliter (IU/mL)
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 22 (only Part A2), Day 29, Day 60 (only Part A2) and Day 90 (only Part A2) after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - Fibrinogen
Unit of measure: gram per milliliter (g/mL)
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 22 (only Part A2), Day 29, Day 60 (only Part A2) and Day 90 (only Part A2) after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - von Willebrand factor antigen (VWF:Ag) and von Willebrand factor activity with gain-of function mutant Glycoprotein Ib fragment [VWF:GPIbM])
Unit of measure: percent
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 22 (only Part A2), Day 29, Day 60 (only Part A2) and Day 90 (only Part A2) after the first dose of APAC
Secondary endpoint 3 - Part A: Major adverse limb event (MALE)- and major adverse cardiovascular event (MACE)-free survival
Unit of measure: percentage of patients
Time frame: Assessed at screening (Day -28 to -1), at Day 29, Day 90 (Part A1) and Day 180 (Part A2) after the first dose of APAC
Secondary endpoint 3 - Part A: Quality of life questionnaire European Quality of life-5 Dimensions-3 Level (EQ-5D-5L)
No unit of measure. This questionnaire uses a scale from 0-100 where higher values mean a better outcome.
Time frame: Assessed at screening (Day -28 to -1), at Day 29, D90 (Part A1) and D180 (Part A2) after the first dose of APAC
Secondary endpoint 3 - Part A: Ischemic pain
Assessed using the visual analog scale ranging from 0-100 where 0 = "No Pain" and 100 = "Worst Pain Imaginable"
Time frame: From screening (Day -28 to -1), at Day 29, D90 (Part A1) and D180 (Part A2) after the first dose of APAC
Secondary endpoint 3 - Part A: Number of participants with ischemic ulcers or gangrene
No unit of measure. This will be assessed as per the clinicians judgement (Normal/Abnormal, Not clinically significant/Abnormal, Clinically significant).
Time frame: From screening (Day -28 to -1), Day 29, D90 (Part A1) and D180 (Part A2) after the first dose of APAC
Secondary endpoint 3 - Part A: Physical performance questionnaire
No unit of measure. This will be assessed by asking participants to report their ability to conduct the following activities: Walking around your home, Walking 1-2 blocks on level ground, Walking 1-2 blocks up a hill, Walking 3-4 blocks on level ground, Hurrying or jogging (as if to catch a bus), Vigorous work or exercise. For each activity, participants will be asked to select one of the following answer options: Extremely limited, Quite a bit limited, Moderately limited, Slightly limited, Not at all limited, Limited for other reason or did not do the activity.
Time frame: From screening (Day -28 to -1), at Day 29, D90 (Part A1) and D180 (Part A2) after the first dose of APAC
Secondary endpoint 1 - Part B: Fontaine classification
No unit of measure
Time frame: Assessed at screening (Day -28 to -1), at Day 29, Day 36, Day 60 and Day 90 after the first dose of APAC
Secondary endpoint 1 - Part B: WIfI scoring
No unit of measure
Time frame: Assessed at screening (Day -28 to -1), at Day 8 (only Part B2), Day 15 (only Part B2), Day 29, Day 36, Day 60 and Day 90 after the first dose of APAC
Secondary endpoint 1 - Part B: Outcome of recanalization (TBI and ABI) at rest
No unit of measure
Time frame: Assessed at screening (Day -28 to -1), at Day 29, Day 36, Day 60 and Day 90 after the first dose of APAC
Secondary endpoint 2 - Part B: Changes in PD and PK, and other blood coagulation biomarkers - Clotting time, clot formation time and activated clotting time
Unit of measure: seconds
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part B2), Day 22 (only Part B2), Day 29 and Day 36 (only Part B2)
Secondary endpoint 2 - Part B: Changes in PD and PK, and other blood coagulation biomarkers - Maximum clot firmness
Unit of measure: millimeter
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part B2), Day 22 (only Part B2), Day 29 and Day 36 (only Part B2)
Secondary endpoint 2 - Part B: Changes in PD and PK and other coagulation parameters - Activated partial thromboplastin time (APTT)
Unit of measure: seconds
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 2, Day 8, Day 15 (only Part B2), Day 22 (only Part B2), Day 29, Day 36 (only Part B2), Day 60 (only Part B2) and Day 90 (only Part B2) after the first dose of APAC
Secondary endpoint 2 - Part B: Changes in PD and PK and other coagulation parameters - Anti-Factor IIa activity
Unit of measure: International Units per milliliter (IU/mL)
Time frame: Assessed at baseline (Day 1), Day 2, Day 8, Day 15 (only Part A2), Day 22 (only Part A2), and Day 29 after the first dose of APAC
Secondary endpoint 2 - Part B: Changes in PD and PK and other coagulation parameters - Anti-Factor Xa activity
Unit of measure: International Units per milliliter (IU/mL)
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 29, Day 36 (only Part B2), Day 60 (only Part B2) and Day 90 (only Part B2) after the first dose of APAC
Secondary endpoint 2 - Part B: Changes in PD and PK and other coagulation parameters - Fibrinogen
Unit of measure: gram per milliliter (g/mL)
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 29, Day 36 (only Part B2), Day 60 (only Part B2) and Day 90 (only Part B2) after the first dose of APAC
Secondary endpoint 2 - Part A: Changes in PD and PK and other coagulation parameters - von Willebrand factor antigen (VWF:Ag) and von Willebrand factor activity with gain-of function mutant Glycoprotein Ib fragment (VWF:GPIbM))
Unit of measure: percent
Time frame: Assessed at screening (Day -28 to -1), baseline (Day 1), Day 29, Day 36 (Part B2), Day 60 (only Part B2) and Day 90 (only Part B2) after the first dose of APAC
Secondary endpoint 3 - Part B: MALE and MACE-free survival
Unit of measure: percentage of patients
Time frame: Assessed at screening (Day -28 to Day -1), at Day 36, Day 90 and Day 180 after the first dose of APAC
Secondary endpoint 3 - Part B: Quality of life questionnaire European Quality of life-5 Dimensions-3 Level (EQ-5D-5L)
No unit of measure. This questionnaire uses a scale from 0-100 where higher values mean a better outcome.
Time frame: Assessed at screening (Day -28 to -1), at Day 36, Day 90 and Day 180 after the first dose of APAC
Secondary endpoint 3 - Part B: Ischemic pain
Assessed using the visual analog scale ranging from 0-100 where 0 = "No Pain" and 100 = "Worst Pain Imaginable"
Time frame: Assessed at screening (Day -28 to -1), at Day 36, Day 90 and Day 180 after the first dose of APAC
Secondary endpoint 3 - Part B: Number of participants with ischemic ulcers or gangrene
No unit of measure. This will be assessed as per the clinicians judgement (Normal/Abnormal, Not clinically significant/Abnormal, Clinically significant).
Time frame: Assessed at screening (Day -28 to -1), at Day 36, Day 90 and Day 180 after the first dose of APAC
Secondary endpoint 3 - Part B: Physical performance questionnaire
No unit of measure. This will be assessed by asking participants to report their ability to conduct the following activities: Walking around your home, Walking 1-2 blocks on level ground, Walking 1-2 blocks up a hill, Walking 3-4 blocks on level ground, Hurrying or jogging (as if to catch a bus), Vigorous work or exercise. For each activity, participants will be asked to select one of the following answer options: Extremely limited, Quite a bit limited, Moderately limited, Slightly limited, Not at all limited, Limited for other reason or did not do the activity.
Time frame: Assessed at screening (Day -28 to -1), at Day 36, Day 90 and Day 180 after the first dose of APAC
Plan to share: No
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