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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

542 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Arterial Disease(PAD) Arterial Occlusive Disease Arteriosclerosis Obliterans Thromboangiitis Obliterans Diabetic Foot Ulcer (DFU) Diabetic Foot Ulcer Ischemic Critical Limb Ischemia (CLI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants exposed to drug NL003 from Phase III Clinical Trials

NL003

Intervention Type DRUG

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

Participants exposed to placebo from Phase III Clinical Trials

Placebo

Intervention Type DRUG

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

Interventions

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NL003

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Participants who refused to provide written informed consent;
* Participants who refused to cooperate with the retrospective or prospective data collection.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No