Hepatitis CPhase 1/2NCT01430000
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
A Phase 1/2 study testing Subcutan implantation of autologus skin graft after ex-vivo treatment in people with Hepatitis C, run by Medgenics Medical Israel Ltd. at 1 site in Israel.
Trial summary
Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Subcutan implantation of autologus skin graft after ex-vivo treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed patient consent form
- Chronic HCV patients in relapse following conventional treatment regimen (INF+Ribavirine) with detectable plasma level of HCV RNA
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
- Screening laboratory values, test, and physical exam within acceptable range
Who cannot join
- Current enrollment in another investigational device or drug study
- Anticipated inability to complete all clinic visits and comply with study procedures
- History of, or any current medical condition, which could impact the safety of the subject during the study
- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
- Alcoholism or substance abuse with <6 documented months of sobriety
- Known allergy or sensitivity to interferons or ribavirin
- Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Prof. Eithan Galun Gene Therapy Institute, Hadassah Medical Center Ein Kerem, Jerusalem, Israel
Jerusalem, Jerusalem, 91120
About this study
Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.
Read the detailed description
The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.
Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure
- Conditions
- Hepatitis C
- Being tested
- Subcutan implantation of autologus skin graft after ex-vivo treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutan implantation of autologus skin graft after ex-vivo treatmentBiological
Subcutan implantation of autologus skin graft after ex-vivo treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients using InfraDure Biopump
All subjects will receive autologous InfraDure Biopump tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to three (3) months following INFRADURE Biopump implantation, with possibility of extension for an additional six months for a total of 9 month post INFRADURE Biopump implantation. Saftey parameters (Adverse events and Serious Adverse Events as well as immediate and long term tolerability are the main safety parameters
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medgenics Medical Israel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eithan Galun, Professor, Principal investigator, No affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430000
- Sponsor's protocol ID
- MG-002-01
- Status last verified
- Apr 2014
- First submitted
- 4 Sep 2011
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
- ClinicalTrials.gov ID
- NCT01430000
- Acronym / sponsor ID
- MG-002-01
- Conditions
- Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medgenics Medical Israel Ltd.Industry (pharma, biotech, devices)
- First posted
- 7 Sep 2011 (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.
Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.
Detailed description
The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.
Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed patient consent form
- Chronic HCV patients in relapse following conventional treatment regimen (INF+Ribavirine) with detectable plasma level of HCV RNA
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
- Screening laboratory values, test, and physical exam within acceptable range
Key exclusion criteria (7 listed)
- Current enrollment in another investigational device or drug study
- Anticipated inability to complete all clinic visits and comply with study procedures
- History of, or any current medical condition, which could impact the safety of the subject during the study
- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
- Alcoholism or substance abuse with <6 documented months of sobriety
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 |
|---|---|---|
| Subcutan implantation of autologus skin graft after ex-vivo treatmentSubcutan implantation of autologus skin graft after ex-vivo treatment | Biological | – |
Primary outcome
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients using InfraDure Biopump
Time frame: 9 months
All subjects will receive autologous InfraDure Biopump tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to three (3) months following INFRADURE Biopump implantation, with possibility of extension for an additional six months for a total of 9 month post INFRADURE Biopump implantation. Saftey parameters (Adverse events and Serious Adverse Events as well as immediate and long term tolerability are the main safety parameters
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 17 Apr 2014.
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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.
Eithan Galun, Professor principal investigator
No affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subcutan implantation of autologus skin graft after ex-vivo treatment in people with Hepatitis C, run by Medgenics Medical Israel Ltd. 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 5 inclusion and 7 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 17 Apr 2014. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients using InfraDure Biopump (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2014.