TP03HN106 in Patients With Critical Limb Ischemia
ConditionCritical Limb Ischemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTalengen Institute of Life Sciences, Shenzhen, P.R. China.
About this trial
Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender;
Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6.
Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week);
During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery;
Disqualifiers
Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products;
Patients with limb gangrene greater than 4 cm2;
Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured);
Patients who require hemodialysis;
Trial design
Design model
Single group
Treatments tested in this trial
TP03HN106
DrugDuring the dose escalation phase, subjects will undergo a dose escalation trial of intravenous injection of TP03HN106 for 5 consecutive days to evaluate the safety and tolerance of the subjects to the injection dose of TP03HN106. The preset initial dose for this experiment is 10U/kg, with gradient doses of 20, 30, 40, and 50U/kg. Observe the subjects receiving the investigational drug for any adverse events (AEs) after daily intravenous injection. During the maintenance treatment phase, the subjects will undergo two consecutive treatment courses at the final dose during the dose escalation phase. During each treatment course, subjects will complete the collection of efficacy and safety data for 14 consecutive days of medication (administered every 2 days) and 14 days of discontinuation to evaluate the efficacy and safety of TP03HN106 for subjects with critical limb ischemia.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall clinical treatment efficacy rate
The VAS score or ulcer area decreases by ≥ 50% compared to baseline when administering day 62, it is considered a clinically effective case. The overall clinical efficacy of patient treatment is calculated according to the following formula: Overall clinical treatment effectiveness rate=(number of clinically effective cases/total cases) × 100% When the calculated overall clinical success rate is ≥ 70%, the entire clinical trial is considered successful.
Time frame
Day 62Secondary outcomes
1
Ankle brachial index, ABI
Changes in ABI of subjects (applicable to patients with ulcers) compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 ABI:The ratio of ankle artery systolic pressure to ipsilateral brachial artery systolic pressure
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 622
TcPO2
Changes in TcPO2 of subjects (applicable to patients with ulcers) compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 TcPO2: transcutaneous oxygen partial pressure
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 623
TBI
Changes in TBI of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 TBI: The ratio of toe artery systolic pressure to ipsilateral brachial artery systolic pressure
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 624
Overall clinical treatment efficacy rate
The VAS score or ulcer area decreases by ≥ 50% compared to baseline when administering day 6, day 14, day 21, day 34, day 49, it is considered a clinically effective case. The overall clinical efficacy of patient treatment is calculated according to the following formula: Overall clinical treatment effectiveness rate=(number of clinically effective cases/total cases) × 100% When the calculated overall clinical success rate is ≥ 70%, the entire clinical trial is considered successful.
Time frame
Day 6, day 14, day 21, day 34, day 49Other outcomes
1
Coagulation function indicators
Changes in coagulation function of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 622
Fibrinogen degradation products (FDP)
Changes in FDP of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 623
Thrombosis 4 items
Changes in thrombosis 4 items of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62
Time frame
Baseline, day 6, day 21, day 34, day 49, and day 624
Computed tomography perfusion (CTP)
Changes in blood volume of subjects compared to baseline during administration of day 34 and day 62
Time frame
Baseline,day 34, day 62Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Talengen Institute of Life Sciences, Shenzhen, P.R. China.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Source ClinicalTrials.gov