UMIN-CTR Clinical Trial

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

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanazawa University Hospital
Department of Gastroenterology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

金沢大学病院（石川県）

Date of disclosure of the study information

2010

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

08

Month

31

Day

Last modified on

2013

Year

09

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002958