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

This is an interventional treatment trial for Asymptomatic Chronic HCV Carriers Read More

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.