Women with chronic hepatitis C genotype 1 older than 60 years old
Conditions
Interventions
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
Sponsors
Gifu University Graduate School of Medicine
Gifu Prefectural Hospital, Gifu Municipal Hospital, Hashima City Hospital, Chuno-Kosei Hospital, Tono-Kosei Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viological response | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between serum vitamin D and vuiological response Safety and effectiveness | — |
Countries
Japan
Contacts
Public ContactMasahito Nagaki
Gifu University Graduate School of Medicine Department of Gastroenterology
Outcome results
None listed