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

NCT07023965 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 542

Last updated 2025-07-11

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Beijing Northland Biotech. Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023965 on ClinicalTrials.gov