Asymptomatic Chronic HCV Carriers Clinical Trial
Official title:
Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
This is an exploratory trial of Bovine Colostrum powder to decrease translocation of
gut-derived microbial products and immune activation in HCV infection.
The study is designed as a single-arm, open-label, before-and after exploratory trial of 10
weeks of Bovine Colostrum Powder (BCP) to reduce translocation of intestinal microbial
products and immune activation in patients suffering from chronic hepatitis C virus (HCV)
infection.
The study population will include HCV-infected (genotype 1) men and women, ≥ 18 years of
age, not receiving anti-viral therapy at the time of enrollment and for at least the
previous 3 months. Having failed previous anti-viral therapy (non responders), HCV
recurrence after 72 weeks of therapy, developed side effects which mandated stopping anti
viral therapy, or not considered eligible for initiation of such treatment, with a plasma
HCV RNA level ≥ 1000 I.U.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment