Status:
WITHDRAWN
Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Asymptomatic Chronic HCV Carriers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00956722
Start Date
January 1 2012
End Date
April 1 2014
Last Update
August 28 2012
Active Locations (1)
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1
Liver Unit, Hadassah Medical Center
Jerusalem, Israel, 91120