NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedChronic hepatitis C
Date of first enrollment2009/10/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)combined with DFPP combined without DFPP

Outcome(s)

Primary OutcomeComparison of liver fat before and at the ninth day of DFPP.
Secondary Outcome1) 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 minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Tatsuya Yamashita
Address 13-1 Takara-machi, Kanazawa, Ishikawa Japan
Telephone 076-265-2861
E-mail
Affiliation Kanazawa University Hospital Department of Gastrenterology
scientific contact
Name Shuichi Kaneko
Address 13-1 Takara-Machi, Kanazawa, Ishikawa Japan
Telephone 076-265-2233
E-mail
Affiliation Kanazawa University Hospital Department of Gastrenterology