UMIN-CTR Clinical Trial

Basic information
Public title	Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Acronym	Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Scientific Title	Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Scientific Title:Acronym	Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the clinical significance of serum vitamin D level in the antiviral therapy of patients with chronic hepatitis C with peginterferon and ribavirin.
Basic objectives2	Others
Basic objectives -Others	Measurement of pretreatment serum vitamin D level in patients who underwent antiviral therapy with peginterferon and ribavirin. Comparison between pretreatment serum vitamin D level and treatment outcome.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison between pretreatment serum vitamin D level and treatment outcome.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis C who underwent antiviral therapy with peginterferon and ribavirin and individuals for whom the clinical backgrounds were matched with patients with chronic hepatitis C (as controls).
Key exclusion criteria	None
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Kozawa
Organization	Gifu University Graduate School of Medicine
Division name	Department of Pharmacology
Zip code
Address	Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL	058-230-6214
Email	okozawa@gifu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Rie Nishiwaki
Organization	Gifu University Graduate School of Medicine
Division name	Department of Pharmacology
Zip code
Address	Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL	058-230-6217
Homepage URL
Email	riemn@gifu-u.ac.jp

Sponsor
Institute	Department of Pharmacology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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Address
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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	2010 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2010 Year 05 Month 31 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004464

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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