UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of vitamin D supplementation on pegylated interferon/ribavirin/simeprevir therapy for chronic hepatitis C genotype 1b: Pilot Study
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuaki Chayama
Organization	graduate school of biomedical science, Hiroshima university.
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Email	chayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Yoshiiku Kawakami
Organization	graduate school of biomedical science, Hiroshima university.
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Homepage URL
Email	kamy4419@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima liver study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013949