Unique ID issued by UMIN | UMIN000004947 |
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Receipt number | 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 18:02:40 |
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
Effects of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
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
Effects of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C
Japan |
Women with chronic hepatitis C genotype 1 older than 60 years old
Hepato-biliary-pancreatic medicine |
Others
YES
To investigate the effects of vitamin D in patients with chronic hepatitis C who are treated with peginterferon alpha 2a/ribavirin
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Viological response
Relationship between serum vitamin D and vuiological response
Safety and effectiveness
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
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
60 | years-old | <= |
Not applicable |
Female
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.
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.
30
1st name | |
Middle name | |
Last name | Masahito Nagaki |
Gifu University Graduate School of Medicine
Department of Gastroenterology
1-1 Yanagido, Gifu 501-1194, Japan
058-230-6308
1st name | |
Middle name | |
Last name | Masahito Nagaki |
Gifu University Graduate School of Medicine
Department of Gastroenterology
1-1 Yanagido, Gifu 501-1194, Japan
058-230-6308
Gifu University Graduate School of Medicine
None
Self funding
Gifu Prefectural Hospital, Gifu Municipal Hospital, Hashima City Hospital, Chuno-Kosei Hospital, Tono-Kosei Hospital
NO
2011 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 01 | Month | 25 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 01 | Month | 25 | Day |
2011 | Year | 01 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005890
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