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

UMIN ID: UMIN000004947

Registered date:01/02/2011

Basic Information

• Recruitment status: Recruiting
• 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
• Secondary Outcome: Relationship between serum vitamin D and vuiological response Safety and effectiveness

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Female
• 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
• Secondary Sponsor: Gifu Prefectural Hospital, Gifu Municipal Hospital, Hashima City Hospital, Chuno-Kosei Hospital, Tono-Kosei Hospital
• Source(s) of Monetary Support: None