UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000402
Receipt number R000000490
Scientific Title A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C
Date of disclosure of the study information 2006/04/17
Last modified on 2011/10/11 08:25:16

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Basic information

Public title

A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C

Acronym

Shonan-Tokai Interferon Research for Serogroup 2 (STIRS2)

Scientific Title

A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C

Scientific Title:Acronym

Shonan-Tokai Interferon Research for Serogroup 2 (STIRS2)

Region

Japan


Condition

Condition

serotype 2 chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

sustained viral response (negative HCV-RNA 24 weeks after the end of treatment)

Key secondary outcomes

(1) percentage of patients in whom drug dose is reduced or treatment is discontinued (2) change in Hgb levels


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

PEG-IFN alpha-2b (1.5ug/kg) + reduced dose ribavirin (400-800 mg)

Interventions/Control_2

PEG-IFN alpha-2b (1.5ug/kg) + standard dose ribavirin (600-1,000mg)

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

(1) genotype 2 chronic hepatitis C (2) patients with viral loads of 100 KIU/mL or more, or patients who did not respond to IFN monotherapy (3) patients satisfying below criteria within 30 days before entry (3-1) leukocyte count with 4000/mm3 or greater (3-2) neutrophil count with 1500/mm3 or greater (3-3) platelet count with 100000/mm3 or greater (3-4) hemoglobin level with 12.0 g/dl or greater

Key exclusion criteria

(1) pregnant women (2) patients allergic to ribavirin or IFN (3) patients with uncontrolled heart diseases (4) patients with abnormal hemoglobin (5) patients with chronic renal diseases (6) patients with severe depression or mental illness (7) patinets with liver cirrhosis or liver failure (8) patients who can not discontinue other antiviral or immunomodulating drugs

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mine, Tetsuya

Organization

Tokai University School of Medicine

Division name

Gastroenterology

Zip code


Address

Boseidai, Isehara, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kagawa, Tatehiro

Organization

Tokai University School of Medicine

Division name

Gastroenterology

Zip code


Address


TEL

0463-93-1121

Homepage URL


Email

kagawa@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tokai University School of Medicine, Department of Gastroenterology

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

2006 Year 04 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

2006 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2006 Year 04 Month 01 Day

Last follow-up date

2010 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2011 Year 04 Month 01 Day

Date analysis concluded

2011 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 04 Month 10 Day

Last modified on

2011 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name