Critical Limb IschemiaPhase 2NCT06482892
TP03HN106 in Patients With Critical Limb Ischemia
A Phase 2 study testing TP03HN106 in people with Critical Limb Ischemia, run by Talengen Institute of Life Sciences, Shenzhen, P.R. China. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- TP03HN106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2024to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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);
- 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;
- 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.
Who cannot join
- 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);
- 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;
Show all 14Show fewer
- During the screening period, subjects 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 white spirit);
- 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);
- Poor compliance or any other situation that the researcher deems unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia
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
- Critical Limb Ischemia
- Being tested
- TP03HN106
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP03HN106Drug
During 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: TP03HN106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 62
Secondary outcomes (5)
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
Measured: Baseline, day 6, day 21, day 34, day 49, and day 62
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
Measured: Baseline, day 6, day 21, day 34, day 49, and day 62
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
Measured: Baseline, day 6, day 21, day 34, day 49, and day 62
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.
Measured: Day 6, day 14, day 21, day 34, day 49
Rutherford grading
Changes in Rutherford grading of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62
Measured: Baseline, day 6, day 21, day 34, day 49, and day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start18 Jul 2024
- Primary completion10 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talengen Institute of Life Sciences, Shenzhen, P.R. China.
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482892
- Sponsor's protocol ID
- TP03HN106-CLI-IIT
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT06482892
- Acronym / sponsor ID
- TP03HN106-CLI-IIT
- Conditions
- Critical Limb Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Talengen Institute of Life Sciences, Shenzhen, P.R. China.University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: TP03HN106 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 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);
Key exclusion criteria (14 listed)
- 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);
- Screening period for patients with liver and kidney failure:
- Patients who require hemodialysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP03HN106During 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. | Drug | Treatment group |
Primary outcome
Overall clinical treatment efficacy rate
Time frame: Day 62
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.
5 secondary outcomes
Ankle brachial index, ABI
Time frame: Baseline, day 6, day 21, day 34, day 49, and day 62
TcPO2
Time frame: Baseline, day 6, day 21, day 34, day 49, and day 62
TBI
Time frame: Baseline, day 6, day 21, day 34, day 49, and day 62
Overall clinical treatment efficacy rate
Time frame: Day 6, day 14, day 21, day 34, day 49
Rutherford grading
Time frame: Baseline, day 6, day 21, day 34, day 49, and day 62
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Limb Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP03HN106 in people with Critical Limb Ischemia, run by Talengen Institute of Life Sciences, Shenzhen, P.R. China. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall clinical treatment efficacy rate (time frame: Day 62). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.