Clinical trial NCT00956722: Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
Official title: Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Asymptomatic Chronic HCV Carriers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons.
timeFrame: 10 weeks
measure: To determine the safety of the administration of oral BCP to patients with chronic HCV
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 10 weeks
measure: 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
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Liver Unit, Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Gadi Lalazar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.