Hepatitis CPhase 1/2NCT01433133
Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients
A Phase 1/2 study testing implantation in people with Hepatitis C, run by Medgenics Medical Israel Ltd..
Trial summary
This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- implantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed patient consent form
- Genotype 3 chronic HCV with detectable HCV RNA
- No previous treatment for HCV infection
- 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 ranges
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
About this study
Official title: Phase I-II, Open Label, Uncontrolled, Dose Escalation Study of the Safety, Tolerability and Biologic Activity of the INFRADURE Biopump Secreting Sustained Interferon Alpha-2b (IFNα), in Combination With Oral Ribavirin for Genotype 3 Newly Diagnosed Hepatitis C Patients
This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation
Read the detailed description
Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from the patient's own skin. The INFRADURE biopump is produced from a micro-organ (MO), typically measuring 30 mm in length and 1.5-2.5 mm diameter, which is harvested directly from the patient's dermis under local anesthesia. The micro-organ can be viably maintained ex-vivo for extended periods of time under standard culture conditions. INFRADURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral INF vectors (HDAd-INF), express and secrete INF. INFRADURE Biopump is monitored ex vivo prior to re-implantation, to attain true INF dosing. The INFRADURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of INF. Each implanted autologous INFRADURE Biopump remains localized under the skin, and is accessible, so that if necessary, it can be removed or ablated at any time. The entire process from harvest to implantation requires 10-14 days
- Conditions
- Hepatitis C
- Being tested
- implantation
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantationBiological
subcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | • Genotype 3 chronic HCV with detectable serum HCV RNA Receives: Biological: implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load: incidence of sustained virologic response (SVR)
Viral load to be measured along the study expecting notable decrease in the viral load by week 24 post intervention
Measured: 24 weeks
Secondary outcomes (4)
Rapid virologic response (RVR)
Measured: Time Frame-Study Week 4
Early virologic response (EVR)
Measured: Time Frame-Study week 12
End-of-treatment response (EOT)
Measured: Time Frame-Study week 48, 104
Rapid virologic response (RVR)
Measured: Evaluation after 4 weeks from treatment day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionMar 2014
Why it stopped: Company strategic decision
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medgenics Medical Israel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433133
- Sponsor's protocol ID
- MG-002-02
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2011
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II, Open Label, Uncontrolled, Dose Escalation Study of the Safety, Tolerability and Biologic Activity of the INFRADURE Biopump Secreting Sustained Interferon Alpha-2b (IFNα), in Combination With Oral Ribavirin for Genotype 3 Newly Diagnosed Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT01433133
- Acronym / sponsor ID
- MG-002-02
- Conditions
- Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company strategic decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medgenics Medical Israel Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 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.
This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation
Detailed description
Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from the patient's own skin. The INFRADURE biopump is produced from a micro-organ (MO), typically measuring 30 mm in length and 1.5-2.5 mm diameter, which is harvested directly from the patient's dermis under local anesthesia. The micro-organ can be viably maintained ex-vivo for extended periods of time under standard culture conditions. INFRADURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral INF vectors (HDAd-INF), express and secrete INF. INFRADURE Biopump is monitored ex vivo prior to re-implantation, to attain true INF dosing. The INFRADURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of INF. Each implanted autologous INFRADURE Biopump remains localized under the skin, and is accessible, so that if necessary, it can be removed or ablated at any time. The entire process from harvest to implantation requires 10-14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: implantation• Genotype 3 chronic HCV with detectable serum HCV RNA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed patient consent form
- Genotype 3 chronic HCV with detectable HCV RNA
- No previous treatment for HCV infection
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
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 |
|---|---|---|
| implantationsubcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b | Biological | 1 |
Primary outcome
Viral Load: incidence of sustained virologic response (SVR)
Time frame: 24 weeks
Viral load to be measured along the study expecting notable decrease in the viral load by week 24 post intervention
4 secondary outcomes
Rapid virologic response (RVR)
Time frame: Time Frame-Study Week 4
Early virologic response (EVR)
Time frame: Time Frame-Study week 12
End-of-treatment response (EOT)
Time frame: Time Frame-Study week 48, 104
Rapid virologic response (RVR)
Time frame: Evaluation after 4 weeks from treatment day 0
Results and safety
The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing implantation in people with Hepatitis C, run by Medgenics Medical Israel Ltd..
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 6 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: stopped early, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early (reason given: Company strategic decision). Results are not available in the source record.
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?
Viral Load: incidence of sustained virologic response (SVR) (time frame: 24 weeks). 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 13 Sep 2016.