UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000897
Receipt number R000000987
Scientific Title A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C
Date of disclosure of the study information 2007/11/17
Last modified on 2013/12/21 18:57:12

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Basic information

Public title

A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C

Acronym

A comparison of peginterferon ribavirin combination therapies

Scientific Title

A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C

Scientific Title:Acronym

A comparison of peginterferon ribavirin combination therapies

Region

Japan


Condition

Condition

chronic hepatitis C with high viral load (>100KIU/ml) and serogroup I

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare peginterferon alfa-2b in combination with ribavirin versus
peginterferon alfa-2a in combination with ribavirin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SVR(sustained virologic response:no detectable hepatitis C virus in their blood 6 months after treatment has ended) 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

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

peginterferon alfa-2b in combination with ribavirin

Interventions/Control_2

peginterferon alfa-2a in combination with ribavirin

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The study is designed to enroll patients with HCV RNA positive.
1.Chronic hepatitis C
2.HCV RNA >=100KIU/ml
3.WBC >=3000/mm3
4.Neutrophil >=1500/mm3
5.Platelet count >=90,000
6.Hemoglobin >=12g/dL
7.Patient who was explained about the study, understood it, and gave the consent form

Key exclusion criteria

The exclusion criteria are as follows:
1.liver disease such as autoimmune hepatitis, coinfection with hepatitis B,
2.severe renal disease, Ccr <50ml/min
3.poorly controlled heart disease
4.depression or psychosomatic disorders
5.Sho-saiko-to treatment within 30 days before interferon administration
6.pregnant or lactating women and women who may be pregnant
7.a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment
8.drug allergy against interferon or ribavirin
9.allergy against biological drugs
10.no prior therapy of peginterferon in combination with ribavirin
11.on other clinical trial
12.any reason which medical doctor regard the patient as unsuitable for this test

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Yoshida

Organization

University of Tokyo

Division name

Department of Gastroenterology, Faculty of Medicine

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

yoshida-2im@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadashi Goto

Organization

University of Tokyo

Division name

Department of Gastroenterology, Faculty of Medicine

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

tadagotou-gi@umin.ac.jp


Sponsor or person

Institute

University of Tokyo
Department of Gastroenterology, Faculty of Medicine

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2007 Year 11 Month 17 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

Completed

Date of protocol fixation

2007 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2007 Year 11 Month 01 Day

Last follow-up date

2013 Year 11 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

2007 Year 11 Month 16 Day

Last modified on

2013 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name