Chronic hepatitis C
Conditions
Interventions
Lactoferrin
Placebo
Sponsors
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)20-74 years of age, 2)Positivity for anti-HCV antibody, 3)An HCV RNA level evaluated within 1 month before entry of 0.5-850 KIU/mL, 4)A sustained elevation of serum ALT levels (more than the upper normal limit) for at least 6 months, 5)A serum ALT level evaluated within 1 month before entry of >=twice the upper normal limit, 6)No evidence of HCC on the basis of ultrasonography or computed tomography performed within 3 months before entry, 7)Adequate bone marrow function [white blood cell count >=4000/mm3, platelet count >=100,000/mm3, and hemoglobin level >=11 g/dL], liver function [total bilirubin level =3.5 g/dL, and serum AST and ALT levels <=200 IU/L], and renal function [normal serum creatinine and blood urea nitrogen levels], 8)Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologic response, defined as a 50% or greater decrease in the serum HCV RNA level at 12 weeks compared with the baseline | — |
Countries
Japan
Contacts
Public ContactHideki Ueno, MD
Lactoferrin Coordinating Office National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed