Treatment for severe leg blood flow issues

A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia

This study is testing a new treatment called TP03HN106 to see if it can help people with severe leg blood flow problems feel better and avoid surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Talengen Institute of Life Sciences, Shenzhen, P.R. China. (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06482892 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of TP03HN106 in patients suffering from critical limb ischemia (CLI), a severe condition characterized by reduced blood flow to the legs, leading to pain, ulcers, and potential amputation. The study aims to evaluate the efficacy of TP03HN106 in promoting thrombolysis to improve blood flow and alleviate symptoms in patients who cannot undergo surgical interventions. Participants will be monitored for improvements in their condition and overall quality of life. The trial is designed for patients with a specific Rutherford score indicating the severity of their CLI.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with critical limb ischemia who cannot undergo surgical treatment.

Not a fit: Patients with mild forms of peripheral arterial disease or those who can undergo surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and quality of life for patients with critical limb ischemia.

How similar studies have performed: While the specific approach of TP03HN106 is novel, similar studies targeting thrombolysis in CLI have shown promise in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

1. When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender;
2. Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6.
3. 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);
4. 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;
5. During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb rest pain caused by lower limb ischemia, with a disease duration of ≥ 2 weeks, and a VAS score of ≥ 40mm and \< 100mm before the first administration; There are limb tissue ulcers caused by lower limb ischemia, with a disease duration of ≥ 2 weeks and limb ulcers (4cm2 ≤ maximum single ulcer area ≤ 25cm2);
6. All subjects with fertility or their spouses must take effective contraceptive measures within 3 months after signing the informed consent form until the completion of the trial;
7. The subjects voluntarily give informed consent and sign an informed consent form (if the subjects and/or their guardians lack reading ability and cannot understand the content of the informed consent, they need to sign together with a fair witness), fully understand the methods and procedures of the experiment, and be able to provide biological samples for testing related indicators in accordance with the experiment requirements.

Exclusion Criteria:

1. Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products;
2. Patients with limb gangrene greater than 4 cm2;
3. Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured);
4. Screening period for patients with liver and kidney failure:
5. Patients who require hemodialysis;
6. Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form;
7. During the screening period, subjects with mental illness, obvious mental disorders or epilepsy, including other individuals with no behavioral or cognitive abilities;
8. Hypertensive patients (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg) who cannot be controlled after standardized treatment in the screening period;
9. Individuals who have received fresh plasma, cold precipitates, or blood products containing TP03HN106 components within one month prior to signing the informed consent form;
10. Those who have participated in clinical trials of other drugs or medical devices within one month before signing the informed consent form;
11. Those who have undergone or plan to undergo surgery during the trial period within one month prior to signing the informed consent form;
12. Alcoholism and/or psychoactive substances, drug abusers and dependents (alcoholism standard: the weekly alcohol intake is more than 21 units (male) and 14 units (female) (1 unit=360 mL beer; or 150 mL wine; or 45 mL white spirit);
13. Miscarriage or termination of pregnancy less than 3 months prior to signing the informed consent form, pregnant women and lactating women (currently breastfeeding or not artificially breastfeeding but less than 6 months after delivery);
14. Poor compliance or any other situation that the researcher deems unsuitable for inclusion.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chunying Guo

Conditions Critical Limb Ischemia