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NCT00956722

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

Withdrawn Phase 1 Last updated 27 August 2012
What this trial tests

Phase 1 trial testing Bovine Colostrum Powder in Asymptomatic Chronic HCV Carriers. Withdrawn.

Timeline
1 January 2012
Primary endpoint
1 January 2014
1 April 2014

Quick facts

Lead sponsorHadassah Medical Organization
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Start date1 January 2012
Primary completion1 January 2014
Estimated completion1 April 2014
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Hadassah Medical Organization — full company profile →

Who can join

18 and older, any sex, with Asymptomatic Chronic HCV Carriers. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Hadassah Medical Organization trials

Trials by the same sponsor.

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Data sources for this page

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