Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C

UMIN ID: C000000176

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2001/05/01
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Lactoferrin
Placebo

Outcome(s)

• Primary Outcome: Virologic response, defined as a 50% or greater decrease in the serum HCV RNA level at 12 weeks compared with the baseline

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude criteria: 1) Positivity for hepatitis B surface antigen, 2) Interferon therapy within 6 months before entry; immunomodulatory or corticosteroid therapy within 3 months before entry; intravenous glycyrrhizin therapy within 1 month before entry, 3) Past or present history of bovine lactoferrin tablets intake, 4) Severe hepatic disease (e.g. autoimmune hepatitis and primary biliary cirrhosis), 5) Other serious medical conditions (e.g. gastrointestinal bleeding, active infection, severe pulmonary disease, and psychiatric disorders), 6) Pregnant or lactating females

Related Information

• Primary Sponsor: National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare