Rationale and design for the study of recombinant human hepatocyte growth factor plasmid in the treatment of patients with chronic limb-threatening ischemia (HOPE CLTI): Randomized, placebo-controlled, double-blind, phase III clinical trials

• Published in: The American heart journal Vol. 254; pp. 88 - 101
• Main Authors: Di, Xiao, Liu, Changwei, Ni, Leng, Ye, Wei, Rong, Zhihua, Zhang, Rui, Niu, Shuai, Li, Fengshi, Zheng, Yuehong, Han, Chengquan, Liu, Yue
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2022; Elsevier Limited
• Subjects: Angiogenesis; Blood vessels; Cardiovascular disease; Cardiovascular system; Chronic Limb-Threatening Ischemia; Clinical trials; Diabetes; Double-blind studies; Drug development; Drug dosages; Effectiveness; Endovascular Procedures; Enrollments; Evaluation; Growth factors; Hepatocyte Growth Factor; Humans; Informed consent; Injection; Ischemia; Ischemia - therapy; Medical imaging; Pain; Patients; Peripheral Arterial Disease; Placebos; Randomization; Safety; Treatment Outcome; Ulcers; Beijing China; China

Although patients with CLTI have benefited from the rapid development of endovascular techniques, many patients are considered unsuitable for revascularization procedures. A previous phase II clinical trial has suggested that recombinant human hepatocyte growth factor plasmid (NL003) can salvage lim...