NCT07023965

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

Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 542 (estimated)
• Sponsor: Beijing Northland Biotech. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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
• Critical Limb Ischemia (CLI)

Interventions

Type	Name	Description
DRUG	NL003	This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.
DRUG	Placebo	This is an observational study, and the interventions have already been administered in the preceding Phase III clinical trials.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-06-17
• Last updated: 2025-07-11

Locations

5 sites across 1 country: China