Actively Recruiting
TP03HN106 in Patients With Critical Limb Ischemia
Led by Talengen Institute of Life Sciences, Shenzhen, P.R. China. · Updated on 2025-04-15
15
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
T
Talengen Institute of Life Sciences, Shenzhen, P.R. China.
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TP03HN106 in Patients With Critical Limb Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at informed consent, any gender
- Clinically diagnosed with critical limb ischemia, Rutherford score 4 to 6
- Unable to receive interventional surgery, previous surgery ineffective, or unwilling to undergo surgery; receiving conventional antiplatelet and vasodilator drugs for at least 1 week before baseline
- Severe stenosis or occlusion in one or more specified lower limb arteries confirmed by ultrasound or CT angiography during screening
- Severe lower limb ischemia symptoms including rest pain lasting 2 weeks or more with VAS score ≥ 40 mm and < 100 mm before first dose, or limb ulcers lasting 2 weeks or more with ulcer size between 4 cm² and 25 cm²
- Effective contraception for fertile subjects or their partners from consent signing until trial completion
- Voluntary informed consent given and ability to provide required biological samples
You will not qualify if you...
- Known allergy to TP03HN106, its components, or human blood products
- Limb gangrene larger than 4 cm²
- Current malignant tumors or uncured previous malignant tumors
- Liver or kidney failure during screening
- Need for hemodialysis
- Stroke (cerebral infarction or hemorrhage) within 3 months before consent
- Mental illness, severe mental disorders, epilepsy, or inability to behave or understand
- Uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg) despite treatment during screening
- Received fresh plasma, cold precipitates, or blood products containing TP03HN106 within 1 month before consent
- Participation in other drug or device clinical trials within 1 month before consent
- Surgery within 1 month before consent or planned during study
- Alcohol or drug abuse exceeding specified limits
- Miscarriage or pregnancy termination within 3 months before consent; pregnant or breastfeeding women
- Poor compliance or other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
C
Chunying Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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