Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
Summary
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor \[HGF\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
Timeline
- Start
- 2020-01-30
- Primary completion
- 2022-07
- Completion
- 2023-01
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Median time to healing was significantly shorter with AMG0001 versus placebo (84 versus 280 days; P=0.007) reads as mixed primary results PMID 41186002 ↗
paper By 6 months, 63.3% of AMG0001-treated participants healed versus 38.5% of placebo (P=0.053). reads as mixed primary results PMID 41186002 ↗
release “【HGF 遺伝子治療用製品（ AMG0001 ）第Ⅱ相臨床試験 の結果】 ・治癒までの期間の中央値は、 AMG0001 治療群では 84 日であったのに対し、プラセボ群では 280 日” reads as met primary endpoint anges.co.jp ↗
release “以上より、 HGF 遺伝子治療用製品（ AMG0001 ）は、中等度の CLTI 患者 の潰瘍完治までの期間を有意 に短縮し、 良好な 安全性が確認されました” reads as met primary endpoint anges.co.jp ↗