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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002415
Receipt No. R000002958
Scientific Title 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)
Date of disclosure of the study information 2010/01/01
Last modified on 2013/09/02

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Basic information
Public title 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)
Acronym Clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP.
Scientific Title 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)
Scientific Title:Acronym Clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP.
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the mechanism of viral eradication therapy with the combination of DFPP and interferon by measuring liver fat content before and after DFPP with MRS.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of liver fat before and at the ninth day of DFPP.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 combined with DFPP
Interventions/Control_2 combined without DFPP
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed chronic hepatitis C patients.
Patients whose written informed consents are obtained.
Key exclusion 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.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Hospital
Division name Department of Gastrenterology
Zip code
Address 13-1 Takara-Machi, Kanazawa, Ishikawa
TEL 076-265-2233
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yamashita
Organization Kanazawa University Hospital
Division name Department of Gastrenterology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2861
Homepage URL
Email

Sponsor
Institute Kanazawa University Hospital
Department of Gastroenterology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 31 Day
Last modified on
2013 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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