An observational study in Peripheral Arterial Disease(PAD), Arterial Occlusive Disease and Arteriosclerosis Obliterans, sponsored by Beijing Northland Biotech. Co., Ltd.. Enrolling by invitation at 5 sites in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Beijing Northland Biotech. Co., Ltd. · Observational
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:
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 542 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Beijing Northland Biotech. Co., Ltd. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants were enrolled from the parent phase III clinical study identified by protocol numbers NCT04274049 and NCT04275323.
Exclusion Criteria:
Drug: NL003
Drug: Placebo
This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.
This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.
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
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.
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
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.
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
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.
Time frame: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
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
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.
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
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.
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
Plan to share: No
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Beijing Northland Biotech. Co., Ltd.