Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load

UMIN ID: UMIN000000646

Registered date:01/03/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C with serotype 1 and high viral load
• Date of first enrollment: 2007/03/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The group of Peg-IFN alpha/rivavirin with EPL therapy
The group of Peg-IFN alpha/rivavirin without EPL therapy

Outcome(s)

• Primary Outcome: 1.The improvement of sustained viral response 2.The frequency of dose reduction of ribavirin due to anemia

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.The complication of the other liver diseases 2.Liver cirrhosis 3.Prick test-positive 4.IFN,rivavirin or EPL sensitivity 5.During pregnancy, the possibility of pregnancy or during lactation 6.Depression 7.The possibility of autoimmune diseases 8.Uncontrolled diabetes 9.Uncontrolled hypertension 10.While taking Sho-saiko-to 11.Febrile condition 12.Hematopenia 13.Poor function of bone marrow, kidney, heart or lung

Related Information

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