Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans

UMIN ID: UMIN000000730

Registered date:04/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Arteriosclerosis obliterans
• Date of first enrollment: 2004/02/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

An AMG0001 formulation (2.5 mg/ml, 1.85 ml/vial) will be prepared before use and administered to 8 sites with ischemia in the target limb, 0.5 mg of AMG0001 per site (total dose: 4.0 mg).
A placebo, an injectable form externally indistinguishable from the AMG0001 formulation, will be prepared before use and administered to 8 sites in the same manner as the AMG0001 formulation.

Outcome(s)

• Primary Outcome: Improvement of pain at rest and ischemic ulcer
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Anges MG, Inc.
• Source(s) of Monetary Support: Anges MG, Inc.
• Secondary ID(s): JapicCTI-050186