UMIN ID: UMIN000001624
Registered date:07/01/2009
Safety of intradermal administration of monosodium urate crystals as a carrier of idiotype cancer vaccine
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | multiple myeloma |
Date of first enrollment | 2007/06/01 |
Target sample size | 12 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Intradermal administration of monosodium urate crystals 2.0 mcg of monosodium urate crystals per administration 20 mcg of monosodium urate crystals per administration 200 mcg of monosodium urate crystals per administration 2.0 mg of monosodium urate crystals per administration |
Outcome(s)
Primary Outcome | Safetiness during three weeks following the administration of monosodium urate crystals |
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Secondary Outcome | Serum level of inflammatory cytokines Decndritic cell count in the peripheral blood |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 60years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Adolecents having major organ injury indicated by elevated level of serum creatinine, total bilirubin or ALT , or having symptomatic congestive heart failure 2) Patients suffering from gout 3) Patients with any of active autoimmune disease 4) Patients with any of active infectious disease 5) Women on (possible) pregnancy or lactation 6) Adolecents judged inadequate by doctor in charge of the patient or the study |
Related Information
Primary Sponsor | National Hospital Organization Awara Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | National Hospital Organization Awara Hospital |
Secondary ID(s) |
Contact
public contact | |
Name | Mitsuaki Tanaka |
Address | 238-1 Kitagata, Awara, Fukui 910-4272, Japan Japan |
Telephone | 0776-79-1211 |
nhoawara-secretary@umin.ac.jp | |
Affiliation | National Hospital Organization Awara Hospital Department of Pharmacy |
scientific contact | |
Name | Hiroshi Tsutani |
Address | 238-1 Kitagata, Awara, Fukui 910-4272, Japan Japan |
Telephone | 0776-79-1211 |
Affiliation | National Hospital Organization Awara Hospital Department of Internal Medicine |