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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000897
Receipt No. 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

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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
Institute University of Tokyo
Department of Gastroenterology, Faculty of Medicine
Institute
Department

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
URL(English) https://upload.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


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