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NCT00956722
Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
Phase 1 trial testing Bovine Colostrum Powder in Asymptomatic Chronic HCV Carriers. Withdrawn.
1 January 2014
Quick facts
| Lead sponsor | Hadassah Medical Organization |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 January 2012 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 April 2014 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Bovine Colostrum Powder — full drug profile →
Conditions studied
- Asymptomatic Chronic HCV Carriers — all drugs for Asymptomatic Chronic HCV Carriers →
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.
-
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
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.
Verify or expand the search:
- PubMed search for NCT00956722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00956722 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hadassah Medical Organization
- Last refreshed: 27 August 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00956722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing