UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000175
Receipt number R000000243
Scientific Title Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.
Date of disclosure of the study information 2005/09/12
Last modified on 2015/09/04 17:21:17

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Basic information

Public title

Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.

Acronym

GLSG PEG/Rib 2005

Scientific Title

Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.

Scientific Title:Acronym

GLSG PEG/Rib 2005

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study will evaluate the optimal treatment period of combination therapy with peginterferon alpha-2b and ribavirin for chronic hepatitis C.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained virological response rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Negative for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48weeks)

Interventions/Control_2

Positive for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48 weeks)

Interventions/Control_3

Positive for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48 weeks) plus IFN alpha-2b (24weeks)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Chronic hepatitis C with genotype Ia/Ib and high titer (more than 100KIU/ml)
(2)Chronic hepatitis confirmed with liver biopsy.
(3)Abnormal ALT

Key exclusion criteria

(1)Complicated with other liver diseases such as autoimmune hepatitis and alcoholic liver injury.
(2)Liver cirrhosis, hepatic failure.
(3)Drug allergy for IFN or ribavirin.
(4)Drug allergy for vaccine.
(5)Administration of other anti-viral or immunomodulatory treatment.
(6)Pregnancy.
(7)Depression.
(8)Complicated with autoimmune disorders.

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Takagi

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

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

TEL

027-220-8127

Email

htakagi@med.gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoru Kakizaki

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

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

TEL

027-220-8127

Homepage URL


Email

kakizaki@showa.gunma-u.ac.jp


Sponsor or person

Institute

Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine

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

2005 Year 09 Month 12 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

Not significant change

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

Completed

Date of protocol fixation

2004 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2009 Year 01 Month 01 Day

Date of closure to data entry

2009 Year 01 Month 01 Day

Date trial data considered complete

2009 Year 01 Month 31 Day

Date analysis concluded

2009 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 12 Day

Last modified on

2015 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name