UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012666 |
|---|---|
| Receipt number | R000013949 |
| Scientific Title | Effect of vitamin D supplementation on pegylated interferon/ribavirin/simeprevir therapy for chronic hepatitis C genotype 1b: Pilot Study |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2016/07/07 11:34:43 |
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Basic information
Public title
Effect of vitamin D supplementation on pegylated interferon/ribavirin/simeprevir therapy for chronic hepatitis C genotype 1b: Pilot Study
Acronym
Triple therapy + vitamin D
Scientific Title
Effect of vitamin D supplementation on pegylated interferon/ribavirin/simeprevir therapy for chronic hepatitis C genotype 1b: Pilot Study
Scientific Title:Acronym
Triple therapy + vitamin 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, ribavirin and simeprevir plus Vitamin D
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
virologic response at 4weeks
Key secondary outcomes
virologic response at2,8,12,24 weeks
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
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
peginterferon alfa-2b, ribavirin and simeprevir plus vitamin D(prior to triple therapy)
Interventions/Control_2
peginterferon alfa-2b, ribavirin and simeprevir plus vitamin D(concurrent with triple therapy)
Interventions/Control_3
peginterferon alfa-2b, ribavirin and simeprevir plus vitamin D(subsequent to triple therapy)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Genotype 1 and high virus load(5logIU/ml < or =)
Key exclusion criteria
1) Patients receiving shosaiko-to
2) Autoimmune hepatitis
3) History of hypersensitivity to PEG-IFN alpha-2b and simeprevir
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
30
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
chayama@hiroshima-u.ac.jp
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
kamy4419@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima liver study group
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
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
広島大学病院 (広島県）、安佐市民病院 (広島県）、広島赤十字・原爆病院 (広島県）、川上消化器内科ｸﾘﾆｯｸ (広島県）、県立広島病院 (広島県）、 広島鉄道病院 (広島県）、中国労災病院 国立病院機構呉医療センター (広島県）、
JA尾道総合病院 (広島県）、 市立三次中央病院 (広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2016 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013949
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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