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.
|Asymptomatic Chronic HCV Carriers||Drug: Bovine Colostrum Powder||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy|
- To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons. [ Time Frame: 10 weeks ]
- To determine the safety of the administration of oral BCP to patients with chronic HCV [ Time Frame: 12 weeks ]
- To determine whether the administration of BCP will reduce HCV RNA levels or the frequency of T cells expressing markers of cellular immune activation in the peripheral blood of HCV-infected, untreated persons. [ Time Frame: 10 weeks ]
- To determine whether the changes in levels of intestinal microbial products in plasma after administration of BCP are associated with changes in HCV RNA levels or the frequency of activated T cells in the peripheral blood [ Time Frame: 10 weeks ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active treatment with Bovine colostrum
Drug: Bovine Colostrum Powder
Bovine Colostrum Powder (Biogard)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956722
|Liver Unit, Hadassah Medical Center|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Gadi Lalazar, MD||Hadassah Medical Center|