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New treatment option for Critical Limb Ischemia
Official title TP03HN106 in Patients With Critical Limb Ischemia
ClinicalTrials.gov ID: NCT06482892
What this study is testing
What is TP03HN106?
TP03HN106 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for critical limb ischemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 treatment surgical treatment, or whose previous treatment surgical treatment is ineffective, or who are unwilling...
- During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or...
- During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb...
You likely can't join if
- people 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);
- Screening period for patients with liver and kidney failure:
- Patients who require hemodialysis;
- Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form;
See the full eligibility criteria
- 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 treatment surgical treatment, or whose previous treatment surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only...
- 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...
- 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 ≥...
- All people 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;
- The people voluntarily give informed consent and sign an informed consent form (if the people and/or their guardians lack reading ability and cannot understand the content of the informed consent, they need to sign...
- people 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);
- Screening period for patients with liver and kidney failure:
- Patients who require hemodialysis;
- Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form;
- During the screening period, people with mental illness, obvious mental disorders or epilepsy, including other individuals with no behavioral or cognitive abilities;
- Hypertensive patients (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg) who cannot be controlled after standardized treatment in the screening period;
- Individuals who have received fresh plasma, cold precipitates, or blood products containing TP03HN106 components within one month prior to signing the informed consent form;
- Those who have participated in clinical trials of other drugs or medical devices within one month before signing the informed consent form;
- Those who have undergone or plan to undergo surgery during the trial period within one month prior to signing the informed consent form;
- 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...
- 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...
- Poor compliance or any other situation that the researcher deems unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.