Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
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|ClinicalTrials.gov Identifier: NCT00956722|
Recruitment Status : Withdrawn
First Posted : August 11, 2009
Last Update Posted : August 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Asymptomatic Chronic HCV Carriers||Drug: Bovine Colostrum Powder||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||April 2014|
Active treatment with Bovine colostrum
Drug: Bovine Colostrum Powder
Bovine Colostrum Powder (Biogard)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956722
|Liver Unit, Hadassah Medical Center|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Gadi Lalazar, MD||Hadassah Medical Center|