Asymptomatic Chronic HCV Carriers Clinical Trial
Official title:
Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
| Verified date | June 2011 |
| Source | Hadassah Medical Organization |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Liver Unit, Hadassah Medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
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. Epub 2006 Nov 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons. | 10 weeks | No | |
| Primary | To determine the safety of the administration of oral BCP to patients with chronic HCV | 12 weeks | Yes | |
| Secondary | 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. | 10 weeks | No | |
| Secondary | 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 | 10 weeks | No |