Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)

Condition(s) studied

Investigational drug(s) / intervention(s)

NL003: This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.

Placebo: This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.

Study 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). 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.

Eligibility

Primary outcome measure(s)

• Incidence of adverse events (AEs) and serious adverse events (SAEs) — Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
• Incidence of benign and malignant tumors — 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 — Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
• Incidence of major cardiovascular and cerebrovascular events — Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
• Pregnancy status and its outcomes — Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
• Amputation-free survival of the trial limb — 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 — 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 — 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.

Trial sites (5)

More Beijing Northland Biotech. Co., Ltd. trials in China

Other trials for the same condition