UMIN ID: C000000176
Registered date:01/10/2005
Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C
Basic Information
Recruitment status | Complete: follow-up complete |
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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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 74years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labor and Welfare |
Secondary ID(s) |
Contact
public contact | |
Name | Hideki Ueno, MD |
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
Telephone | 03-3542-2511 |
hiueno@ncc.go.jp | |
Affiliation | Lactoferrin Coordinating Office National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division |
scientific contact | |
Name | Takuji Okusaka, MD, PhD |
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
Telephone | 03-3542-2511 |
Affiliation | National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division |