Asymptomatic Chronic HCV CarriersPhase 1NCT00956722
Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
A Phase 1 study testing Bovine Colostrum Powder in people with Asymptomatic Chronic HCV Carriers, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Chronic HCV Carriers
- What is being tested?
- Bovine Colostrum Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asymptomatic Chronic HCV Carriers
- Being tested
- Bovine Colostrum Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Colostrum PowderDrug
Bovine Colostrum Powder (Biogard)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active treatment with Bovine colostrum Receives: Drug: Bovine Colostrum Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons.
Measured: 10 weeks
To determine the safety of the administration of oral BCP to patients with chronic HCV
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 10 weeks
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Chronic HCV CarriersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Gadi Lalazar, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956722
- Sponsor's protocol ID
- Immuron Travelan HCV
- Status last verified
- Jun 2011
- First submitted
- 10 Aug 2009
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17115046
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy
- ClinicalTrials.gov ID
- NCT00956722
- Acronym / sponsor ID
- Immuron Travelan HCV
- Conditions
- Asymptomatic Chronic HCV Carriers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Bovine Colostrum PowderActive treatment with Bovine colostrum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy or Breast-Feeding
- Continuous use of the following medications for more than 3 days within 30 days of study entry:
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Colostrum PowderBovine Colostrum Powder (Biogard) | Drug | Treatment |
Primary outcome
To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons.
Time frame: 10 weeks
To determine the safety of the administration of oral BCP to patients with chronic HCV
Time frame: 12 weeks
2 secondary outcomes
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.
Time frame: 10 weeks
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
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- Background: PubMed 17115046Brenchley 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gadi Lalazar, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bovine Colostrum Powder in people with Asymptomatic Chronic HCV Carriers, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if the administration of BCP will reduce the levels of intestinal microbial products in the bloodstream of HCV-infected, untreated persons. (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.