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

ENROLLING BY INVITATION

NCT07023965

Sponsor: Beijing Northland Biotech. Co., Ltd.

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.

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

Key Details

Gender

All

Age Range

20 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

542

Start Date

2025-06-30

Completion Date

2027-12-31

Last Updated

2025-07-11

Healthy Volunteers

No

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

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.

Locations (5)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

zhongshan Hospital Affiliated of Dalian University

Dalian, Shenyang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, China

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