UMIN ID: UMIN000002415
Registered date:01/01/2010
A clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP (Double filtration plasmapheresis) measured by MRS(Magenetic Resonance Spectroscopy)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Chronic hepatitis C |
Date of first enrollment | 2009/10/01 |
Target sample size | 20 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | combined with DFPP combined without DFPP |
Outcome(s)
Primary Outcome | Comparison of liver fat before and at the ninth day of DFPP. |
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Secondary Outcome | 1) Comparison of HCV-RNA before, 4weeks and 12weeks after the initiation of DFPP. 2) Comparison of the amount of liver fat 4weeks and 12weeks after the initiation of DFPP. 3) Comparison of blood triglyceride and serum ferritin before, 4weeks and 12weeks after the initiation of DFPP. |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Patients ever experienced shock during extracorporeal therapy. 2) Patients who has previous history of hypersensitivity for biological pruducts such as interferon and vaccines. 3) Patients who are now being administered shoo-saikoto. 4) Patients with autoimmune hepatitis. 5) Patients ever experienced a hyper-sensitivity against nucleoside analogues( aciclovir, ganciclovir, vidarabine etc). 6) Patients with uncontrollable cardiac disorder( myocardial infarction, heart failure, arrhythmia) . 7) Patients with hemoglobinopathy (thalassemia, drepanocytic anemia). 8) Patients with chronic renal failure, or whose creatine clearances are under 50mL/min. 9) Patients with serious depression, serious mental state such as suicidal ideation, suicide attempt, or with those histories. 10) Patients with severe hepatic dysfunction. 11) Patients whose platelet numbers are less than 50,000/L upon registration or before the first DFPP. 12) Patients whose fibrinogen levels are less than 100mg/dL upon registration or before the first DFPP. 13) Patients installed or planted with metals( including metal powder) , cardiac pacemaker, implantable nerve stimulator, implantable defibrillator, or cerebrospinal drain tube. 14) Patients who had participated in other clinical researches or clinical trials. 15) Pregnant women, nursing women, or possible pregnant. 16) Additionally, patients who had been judged as unsuitable for this clinical research by the doctors. |
Related Information
Primary Sponsor | Kanazawa University Hospital Department of Gastroenterology |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Tatsuya Yamashita |
Address | 13-1 Takara-machi, Kanazawa, Ishikawa Japan |
Telephone | 076-265-2861 |
Affiliation | Kanazawa University Hospital Department of Gastrenterology |
scientific contact | |
Name | Shuichi Kaneko |
Address | 13-1 Takara-Machi, Kanazawa, Ishikawa Japan |
Telephone | 076-265-2233 |
Affiliation | Kanazawa University Hospital Department of Gastrenterology |