UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001170
Receipt number R000001430
Scientific Title Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road
Date of disclosure of the study information 2014/05/01
Last modified on 2015/08/30 10:19:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road

Acronym

GLSG, 2008, Pegasys

Scientific Title

Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road

Scientific Title:Acronym

GLSG, 2008, Pegasys

Region

Japan


Condition

Condition

chronic hepatitis C

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of short-term PEG-IFN alpha therapy for chronic hepatitis C patients with genotype 2 and low viral load with early dissapearance of HCV-RNA by PEG-IFN alpha.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

HCV-RNA

Key secondary outcomes

transaminase


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

a group of short-term PEG-IFN alpha therapy

Interventions/Control_2

a group of ordinary-term PEG-IFN alpha therapy

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Chronic hepatitis C
genotype 2
positive test of HCV-RNA and less than 5 LogIU/ml of HCV-RNA viral load
abnormal transaminase
negative test of HBsAg

Key exclusion criteria

liver dysfunction with other causes
Allergy to Interferon (IFN)
during pregnancy
Severe comlication-especially,
poor hematopoiesis, renal, cardiac or respiratory function

Target sample size

220


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Sato

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

3-39-15 Showa, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-8127

Email

satoken@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Sato

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

3-39-15 Showa, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-8127

Homepage URL


Email

satoken@gunma-u.ac.jp


Sponsor or person

Institute

Gunma Liver Study Group

Institute

Department

Personal name



Funding Source

Organization

Gunma Liver Study Group

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



Other administrative information

Date of disclosure of the study information

2014 Year 05 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

2008 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2008 Year 05 Month 01 Day

Last follow-up date

2013 Year 10 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

2008 Year 06 Month 02 Day

Last modified on

2015 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name