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

Beijing Northland Biotech

Status: Invitation-only

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

Treatments: Drug: Placebo; Drug: NL003

Study type: Observational

Funder types: Industry

Identifiers

NCT07023965

NL003-CLI-III-L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 542 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

542 participants in 2 patient groups

Participants exposed to drug NL003 from Phase III Clinical Trials

Treatment:

Drug: NL003

Participants exposed to placebo from Phase III Clinical Trials

Treatment:

Drug: Placebo