UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003721
Receipt No. R000004177
Scientific Title peginterferon alfa-2b and ribavirin plus Vitamin D for chronic hepatitis C : An open-label randomized controlled trial.
Date of disclosure of the study information 2010/06/07
Last modified on 2013/06/27

* 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 peginterferon alfa-2b and ribavirin plus Vitamin D for chronic hepatitis C : An open-label randomized controlled trial.
Acronym Trial D
Scientific Title peginterferon alfa-2b and ribavirin plus Vitamin D for chronic hepatitis C : An open-label randomized controlled trial.
Scientific Title:Acronym Trial D
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy of peginterferon alfa-2b and ribavirin plus Vitamin D
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes virologic response at 24weeks
Key secondary outcomes virologic response at
4,8,12,16,20,24,48,72weeks and sustend virologic response

Safety ( moniterd clinical and laboratory evaluation)

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 peginterferon alfa-2b and ribavirin plus vitamin D
Interventions/Control_2 peginterferon alfa-2b and 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 genotype 1 and high virus load
Key exclusion criteria 1) Patients receiving shosaiko-to
2) Autoimmune hepatitis
3) History of hypersensitivity to PEG-IFN alpha-2b
4) History of hypersensitivity to biological products such as vaccine
5) Decompenstated liver cirrhosis
6) HCC, malignat tumor
7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
8) Pregnant or lactating women and women who may be pregnant
9) Judged by investigator not to be appropriate for inclusion in this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization graduate school of biomedical science, Hiroshima university
Division name Department and medicine and molecular science
Zip code
Address 1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL 082-257-5190
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiiku Kawakami
Organization graduate school of biomedical science, Hiroshima university
Division name Department and medicine and molecular science
Zip code
Address 1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL 082-257-5190
Homepage URL
Email

Sponsor
Institute Hiroshima liver study group
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 川上消化器内科クリニック(広島県)、広島赤十字原爆病院(広島県)、JA尾道総合病院(広島県)、県立広島病院(広島県)、呉医療センター(広島県)、安佐市民病院(広島県)、中国労災病院(広島県)、広島鉄道病院(広島県)、三次中央病院(広島県)、放射線影響研究所(広島県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 07 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
2010 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2013 Year 12 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
2010 Year 06 Month 07 Day
Last modified on
2013 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.