Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Biological: implantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Viral Load: incidence of sustained virologic response (SVR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Viral load to be measured along the study expecting notable decrease in the viral load by week 24 post intervention
- Rapid virologic response (RVR) [ Time Frame: Time Frame-Study Week 4 ] [ Designated as safety issue: No ]
- Early virologic response (EVR) [ Time Frame: Time Frame-Study week 12 ] [ Designated as safety issue: No ]
- End-of-treatment response (EOT) [ Time Frame: Time Frame-Study week 48, 104 ] [ Designated as safety issue: No ]
- Rapid virologic response (RVR) [ Time Frame: Evaluation after 4 weeks from treatment day 0 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
• Genotype 3 chronic HCV with detectable serum HCV RNA
|
Biological: implantation
subcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medgenics Medical Israel Ltd. |
| ClinicalTrials.gov Identifier: | NCT01433133 History of Changes |
| Other Study ID Numbers: | MG-002-02 |
| Study First Received: | September 5, 2011 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Israel: Ministry of Health Israel |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2b Interferons Reaferon |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013