Peripheral Arterial Disease(PAD)NCT07023965
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
An observational study of Peripheral Arterial Disease(PAD) and Arterial Occlusive Disease, run by Beijing Northland Biotech. Co., Ltd. at 5 sites in China.
Trial summary
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans
- What is being tested?
- NL003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 542 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jun 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were enrolled from the parent phase III clinical study identified by protocol numbers NCT04274049 and NCT04275323.
Who may be able to join
- Participants who have previously enrolled in Phase III clinical trials of recombinant human hepatocyte growth factor plasmid injection (Donaperminogene Seltoplasmid Injection) for the treatment of critical limb ischemia (including ulcers and rest pain) and have received at least one dose of the treatment.
Who cannot join
- Participants who refused to provide written informed consent;
- Participants who refused to cooperate with the retrospective or prospective data collection.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
Chifeng Municipal Hospital
Chifeng, Neimenggu, 024000
zhongshan Hospital Affiliated of Dalian University
Dalian, Shenyang
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
About this study
Official title: Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are:
- First, what medical problems do participants have after taking drug NL003 to treat CLI?
- Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ?
Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.
Read the detailed description
This study is a multicenter, open-label, long-term follow-up cohort study. A remote follow-up system is recommended as a tool for the study, however, in-person visits or phone calls at the research center will be conducted if remote follow-up is not feasible. The study will retrospectively collect data from the last visit in the parent Phase III study and prospectively gather data following informed consent. It will continue until at least 36 months after the first dose administered to the last enrolled participant.
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans, Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Ischemic
- Being tested
- NL003, Placebo
- Keywords
- HGF, Critical Limb Ischemia, Gene therapy
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Arteriosclerosis Obliterans, Thromboangiitis Obliterans, Diabetic Foot, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NL003Drug
This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.
PlaceboDrug
This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| Participants exposed to drug NL003 from Phase III Clinical Trials | Not described Receives: Drug: NL003 | |
| Participants exposed to placebo from Phase III Clinical Trials | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of benign and malignant tumors
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of significant vision loss, blindness, or other obvious visual abnormalities
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of major cardiovascular and cerebrovascular events
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Pregnancy status and its outcomes
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival of the trial limb
Amputation-free survival of the trial limb is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb or death due to any cause, whichever occurs first.
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization composite endpoint
Amputation-free survival or target vessel revascularization composite endpoint is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb, death due to any cause, or target vessel revascularization* of the trial limb, whichever occurs first.*Target vessel revascularization: bypass grafting, endovascular revascularization, thrombectomy, or thrombolysis of the trial limb.
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint
Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb, death due to any cause, or target vessel revascularization and neovascularization therapies (including stem cell or gene therapy) of the trial limb, whichever occurs first.
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Secondary outcomes (11)
All-cause mortality rate, time to death
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Major amputation rate of the trial limb (amputation plane above the ankle)
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Minor amputation rate of the trial limb (below the ankle, including toe amputation)
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of target vessel revascularization of the trial limb
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Rehospitalization rate for worsening ischemic symptoms of the trial limb
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of death due to acute myocardial infarction or stroke
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Time to amputation of the trial limb
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Level of amputation of the trial limb (above the knee, knee-ankle amputation, below the ankle amputation/toe amputation)
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in Rutherford classification of the trial limb compared to baseline at first dose
The Rutherford classification is a standardized system used to assess the severity of peripheral arterial disease (PAD) in the trial limb. It ranges from category 0 (asymptomatic) to category 6 (ischemic rest pain with gangrene). Higher categories indicate more severe disease. The change in Rutherford classification will be measured by comparing the classification at the first dose to the baseline classification.
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in rest pain of the trial limb assessed by Numeric Rating Scale (NRS) compared to baseline at first dose
The NRS is a pain assessment tool that ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. A higher score on the NRS indicates worse pain. The change in rest pain will be determined by comparing the NRS score at the first dose to the baseline NRS score.
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in ulceration/necrosis of the trial limb compared to baseline at first dose
Measured: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023965
- Sponsor's protocol ID
- NL003-CLI-III-L
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT07023965
- Acronym / sponsor ID
- NL003-CLI-III-L
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans, Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Ischemic
- Keywords
- HGF, Critical Limb Ischemia, Gene therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (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.
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are:
- First, what medical problems do participants have after taking drug NL003 to treat CLI?
- Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ?
Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.
Detailed description
This study is a multicenter, open-label, long-term follow-up cohort study. A remote follow-up system is recommended as a tool for the study, however, in-person visits or phone calls at the research center will be conducted if remote follow-up is not feasible. The study will retrospectively collect data from the last visit in the parent Phase III study and prospectively gather data following informed consent. It will continue until at least 36 months after the first dose administered to the last enrolled participant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants exposed to drug NL003 from Phase III Clinical Trials | – | Drug: NL003 |
| Participants exposed to placebo from Phase III Clinical Trials | – | Drug: Placebo |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were enrolled from the parent phase III clinical study identified by protocol numbers NCT04274049 and NCT04275323.
Key inclusion criteria (1 listed)
- Participants who have previously enrolled in Phase III clinical trials of recombinant human hepatocyte growth factor plasmid injection (Donaperminogene Seltoplasmid Injection) for the treatment of critical limb ischemia (including ulcers and rest pain) and have received at least one dose of the treatment.
Key exclusion criteria (2 listed)
- Participants who refused to provide written informed consent;
- Participants who refused to cooperate with the retrospective or prospective data collection.
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 |
|---|---|---|
| NL003This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials. | Drug | Participants exposed to drug NL003 from Phase III Clinical Trials |
| PlaceboThis is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials. | Drug | Participants exposed to placebo from Phase III Clinical Trials |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of benign and malignant tumors
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of significant vision loss, blindness, or other obvious visual abnormalities
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of major cardiovascular and cerebrovascular events
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Pregnancy status and its outcomes
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival of the trial limb
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival of the trial limb is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb or death due to any cause, whichever occurs first.
Amputation-free survival or target vessel revascularization composite endpoint
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization composite endpoint is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb, death due to any cause, or target vessel revascularization* of the trial limb, whichever occurs first.*Target vessel revascularization: bypass grafting, endovascular revascularization, thrombectomy, or thrombolysis of the trial limb.
Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint is one of the key endpoints for efficacy assessment. The time from the first dose administration to the occurrence of amputation above the ankle of the trial limb, death due to any cause, or target vessel revascularization and neovascularization therapies (including stem cell or gene therapy) of the trial limb, whichever occurs first.
11 secondary outcomes
All-cause mortality rate, time to death
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Major amputation rate of the trial limb (amputation plane above the ankle)
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Minor amputation rate of the trial limb (below the ankle, including toe amputation)
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of target vessel revascularization of the trial limb
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Rehospitalization rate for worsening ischemic symptoms of the trial limb
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of death due to acute myocardial infarction or stroke
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Time to amputation of the trial limb
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Level of amputation of the trial limb (above the knee, knee-ankle amputation, below the ankle amputation/toe amputation)
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in Rutherford classification of the trial limb compared to baseline at first dose
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in rest pain of the trial limb assessed by Numeric Rating Scale (NRS) compared to baseline at first dose
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Change in ulceration/necrosis of the trial limb compared to baseline at first dose
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease(PAD) and Arterial Occlusive Disease, run by Beijing Northland Biotech. Co., Ltd. at 5 sites 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose). The study lists 8 primary outcomes in all. 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 11 Jul 2025.