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

Last updated: July 8, 2025
Sponsor: Beijing Northland Biotech. Co., Ltd.
Overall Status: Active - Enrolling

Phase

N/A

Condition

Vascular Diseases

Intermittent Claudication

Claudication

Treatment

NL003

Placebo

Clinical Study ID

NCT07023965
NL003-CLI-III-L
  • Ages 20-85
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants who have previously enrolled in Phase III clinical trials ofrecombinant human hepatocyte growth factor plasmid injection (DonaperminogeneSeltoplasmid Injection) for the treatment of critical limb ischemia (includingulcers and rest pain) and have received at least one dose of the treatment.

Exclusion

Exclusion Criteria:

  • Participants who refused to provide written informed consent;

  • Participants who refused to cooperate with the retrospective or prospective datacollection.

Study Design

Total Participants: 542
Treatment Group(s): 2
Primary Treatment: NL003
Phase:
Study Start date:
June 30, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100032
    China

    Site Not Available

  • Chifeng Municipal Hospital

    Chifeng, Neimenggu 024000
    China

    Site Not Available

  • zhongshan Hospital Affiliated of Dalian University

    Dalian, Shenyang
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an,
    China

    Site Not Available

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