Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
- Conditions
- Arteriosclerosis obliterans
- Registration Number
- JPRN-UMIN000000730
- Lead Sponsor
- Anges MG, Inc.
- Brief Summary
Analysis of efficacy was performed in 40 patients with critical limb ischemia (CLI). The primary end point was the improvement of rest pain in patients without ulcers (Rutherford 4) or the reduction of ulcer size in patients with ulcer(s) (Rutherford 5). The overall improvement rate of the primary end point was 70.4% (19/27) in HGF group and 30.8% (4/13) in placebo group, showing a significant difference (P=0.014). In Rutherford 5 patients, HGF achieved a significantly higher improvement rate (100% [11/11]) than placebo (40% [2/5]; P=0.018). HGF plasmid also improved QOL. There were no major safety problems. HGF gene therapy is safe and effective for CLI. Gene Ther. 2010 Sep;17(9):1152-61. Epub 2010 Apr 15.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1. Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone 2. Patients in whom alcohol or drug dependence had been noted 90 days or less before informed consent was obtained or who had been treated for it 3. Past history of or complication with cancer 4. Patients with serious cardiac, hepatic, renal, or hematological disease 5. Patients with intercurrent hepatitis B or C, AIDS, or ATL 6. Patients who underwent revascularization or amputation (not necrotomy) 90 days or less before giving informed consent 7. Patients who underwent sympathectomy or sympathetic block 180 days or less before giving informed consent 8. Patients with an invasive infectious disease which is difficult to control with antibiotics 9. Patients with proliferating diabetic retinopathy (untreated or in the middle or late stage of proliferating retinopathy) or neovascularization-type age-related macular degeneration 10. Participation in another clinical trial 90 days or less before giving informed consent 11. Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the trial 12. Past history of cell therapy 13. Past history of gene therapy 14. Blood sampling (or donation) of 200 ml or more, 30 days or less before giving informed consent, or 400 ml or more, 90 (120 in the case of women) days or less before giving informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of pain at rest and ischemic ulcer
- Secondary Outcome Measures
Name Time Method Time course of pain at rest and Ischemic ulcer Ankle brachial index Fontaine classification Angiogenesis Incidence of subjects without analgesic Quality of life Amputation of drug-administered leg Adverse events Investigations and vital signs Serum HGF level Serum anti-HGF antibody Serum anti-Escherichia protein antibody Serum anti-DNA antibody