long-term low-dose Natural IFN-alpha for patients with chronic hepatits C

UMIN ID: C000000228

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2004/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

intervention:Sumiferon
control:SNMC

Outcome(s)

• Primary Outcome: liver function-transaminase virological response
• Secondary Outcome: Incidence of hepatocellular carcinoma safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1 Allergy to IFN or cow-derived substances 2 Allergy to biological products such as vaccine 3 essential to administration of sho- saiko-to 4 liver diseases with other causes such as autoimmune hepatitis, alcoholic hepatitis 5 patients with previously-diagnosed HCC 6 Leucopenia(less than 2000) or thrombopenia (less than 50000) 7 central nerve sytem manifestation or psychosomatic disorders 8 severe complications 9 during pregnancy or lactation 10 inappropriate subjects judged by physicinas 11 patients hoping for certain therapeutic methods

Related Information

• Primary Sponsor: Gunma Liver Study Group
• Source(s) of Monetary Support: Gunma Liver Study Group