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Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy

NCT00956722 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Asymptomatic Chronic HCV Carriers

Interventions

DRUG

Bovine Colostrum Powder

Bovine Colostrum Powder (Biogard)

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Gadi Lalazar, MD · Hadassah Medical Organization

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956722 on ClinicalTrials.gov