hyperimmune bovine colostrum - travelan™ for patients with chronic hepatitis c virus infection not responding to standard therapy

Conditions: Asymptomatic Chronic HCV Carriers

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.


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.