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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00956722
First received: August 10, 2009
Last updated: August 27, 2012
Last verified: June 2011
  Purpose

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 Intervention Phase
Asymptomatic Chronic HCV Carriers
Drug: Bovine Colostrum Powder
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the safety of the administration of oral BCP to patients with chronic HCV [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
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)
Arms Assigned Interventions
Experimental: Treatment
Active treatment with Bovine colostrum
Drug: Bovine Colostrum Powder
Bovine Colostrum Powder (Biogard)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HCV infection (genotype 1), as documented by a positive anti HCV titer, and confirmed by positive HCV RNA.
  • Non responder to previous antiviral therapy, HCV recurrence after 72 weeks of therapy, previous antiviral therapy stopped due to side effects, or not a candidate for treatment with interferon + ribavirin.
  • No antiviral therapy for at least 3 months.
  • HCV RNA ≥1,000 IU obtained within 30 days prior to study entry.
  • Not currently listed for liver transplantation
  • Female study subjects of reproductive potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure (hysterectomy or bilateral oophorectomy) must have a negative serum or urine pregnancy test performed within 48 hours before initiating the protocol-specified medication(s) unless otherwise specified by product labeling.
  • All study subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
  • If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication. NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:

    • Condoms (male or female) with or without a spermicidal agent. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission;
    • Diaphragm or cervical cap with spermicide;
    • IUD;
    • Hormonal-based contraception.
  • Study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:

    • Physician report/letter;
    • Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy);
    • Discharge summary;
    • Laboratory report of azoospermia;
    • FSH measurement elevated into the menopausal range as established by the reporting laboratory.
  • Men and women age > 18 years.
  • Ability and willingness of subject or legal guardian/representative to provide informed consent.

Exclusion Criteria:

  • Pregnancy or Breast-Feeding
  • Continuous use of the following medications for more than 3 days within 30 days of study entry:

    • Immunosuppressives;
    • Immune modulators;
    • Systemic glucocorticoids;
    • Anti-neoplastic agents;
    • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956722

Locations
Israel
Liver Unit, Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Gadi Lalazar, MD Hadassah Medical Center
  More Information

Publications:
Responsible Party: Grant Rawling, Immuron Ltd.
ClinicalTrials.gov Identifier: NCT00956722     History of Changes
Other Study ID Numbers: Immuron Travelan HCV
Study First Received: August 10, 2009
Last Updated: August 27, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014