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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004947
Receipt No. R000005890
Scientific Title An open-label randomized controlled study on the efficacy and safety of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Date of disclosure of the study information 2011/02/01
Last modified on 2011/01/25

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Basic information
Public title An open-label randomized controlled study on the efficacy and safety of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Acronym Effects of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Scientific Title An open-label randomized controlled study on the efficacy and safety of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Scientific Title:Acronym Effects of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Region
Japan

Condition
Condition Women with chronic hepatitis C genotype 1 older than 60 years old
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effects of vitamin D in patients with chronic hepatitis C who are treated with peginterferon alpha 2a/ribavirin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Viological response
Key secondary outcomes Relationship between serum vitamin D and vuiological response
Safety and effectiveness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Alphacalcidol (1.0 microgram/day) for 4 weeks before alphacalcidol (1.0 microgram/day) plus peginterferon alpha 2a/ribavirin for 48-72 weeks
Interventions/Control_2 Peginterferon alpha 2a/ribavirin for 48-72 weeks
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
60 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Adult women aged more than 60 years testing positive for anti-HCV, with consistent detection of HCV RNA above 100,000 IU/ml, by reverse-transcription polymerase chain reaction and elevated serum ALT activities are eligible for enrollment.
Key exclusion criteria Patients are excluded if they have decompensated liver diseases, other causes of liver diseases, hepatitis B infection, hemoglobin values <12 g/dl, white blood cell count <3000/ul, thrombocytopenia <90,000/ul, neoplastic, severe cardiac, neurological, autoimmune or thyroid diseases. Also excluded were patients with alcohol or drug abuse, women who were pregnant or considering pregnancy in the next 18 months, or men whose partners were considering pregnancy in the next 18 months.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Nagaki
Organization Gifu University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL 058-230-6308
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Nagaki
Organization Gifu University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL 058-230-6308
Homepage URL
Email

Sponsor
Institute Gifu University Graduate School 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 Gifu Prefectural Hospital, Gifu Municipal Hospital, Hashima City Hospital, Chuno-Kosei Hospital, Tono-Kosei Hospital
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
2011 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2011 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005890

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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