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

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Notable Primary endpoints: 5 to 8
    • Start date: Jun 6, 2025 to Jun 30, 2025
    • Secondary endpoints: 14 to 11
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07023965
Lead Sponsor Beijing Northland Biotech. Co., Ltd.
Conditions
(from sponsor)
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans, Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Ischemic, Critical Limb Ischemia (CLI)
Related terms Arterial Occlusive Diseases, Arteriosclerosis Obliterans, Chronic Limb-Threatening Ischemia, Diabetic Foot, Peripheral Arterial Disease, Thromboangiitis Obliterans
Enrollment 542 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov