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

NCT ID: NCT00956722

Last Updated: 2012-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Active treatment with Bovine colostrum

Group Type: EXPERIMENTAL

Bovine Colostrum Powder

Intervention Type: DRUG

Bovine Colostrum Powder (Biogard)

Interventions

Bovine Colostrum Powder

Bovine Colostrum Powder (Biogard)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Immuron Ltd.

Principal Investigators

Gadi Lalazar, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Liver Unit, Hadassah Medical Center

Jerusalem, , Israel

Countries

Israel

References

Brenchley JM, Price DA, Schacker TW, Asher TE, Silvestri G, Rao S, Kazzaz Z, Bornstein E, Lambotte O, Altmann D, Blazar BR, Rodriguez B, Teixeira-Johnson L, Landay A, Martin JN, Hecht FM, Picker LJ, Lederman MM, Deeks SG, Douek DC. Microbial translocation is a cause of systemic immune activation in chronic HIV infection. Nat Med. 2006 Dec;12(12):1365-71. doi: 10.1038/nm1511. Epub 2006 Nov 19.

Reference Type: BACKGROUND

PMID: 17115046 (View on PubMed)

Other Identifiers

Immuron Travelan HCV

Identifier Type: -

Identifier Source: org_study_id