UMIN ID: UMIN000004947
Registered date:01/02/2011
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
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Women with chronic hepatitis C genotype 1 older than 60 years old |
Date of first enrollment | 2011/02/01 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Alphacalcidol (1.0 microgram/day) for 4 weeks before alphacalcidol (1.0 microgram/day) plus peginterferon alpha 2a/ribavirin for 48-72 weeks Peginterferon alpha 2a/ribavirin for 48-72 weeks |
Outcome(s)
Primary Outcome | Viological response |
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Secondary Outcome | Relationship between serum vitamin D and vuiological response Safety and effectiveness |
Key inclusion & exclusion criteria
Age minimum | 60years-old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | Gifu University Graduate School of Medicine |
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Secondary Sponsor | Gifu Prefectural Hospital, Gifu Municipal Hospital, Hashima City Hospital, Chuno-Kosei Hospital, Tono-Kosei Hospital |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Masahito Nagaki |
Address | 1-1 Yanagido, Gifu 501-1194, Japan Japan |
Telephone | 058-230-6308 |
Affiliation | Gifu University Graduate School of Medicine Department of Gastroenterology |
scientific contact | |
Name | Masahito Nagaki |
Address | 1-1 Yanagido, Gifu 501-1194, Japan Japan |
Telephone | 058-230-6308 |
Affiliation | Gifu University Graduate School of Medicine Department of Gastroenterology |