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Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump

This study is not yet open for participant recruitment.
Verified September 2011 by Medgenics Medical Israel Ltd.
Sponsor:
Information provided by (Responsible Party):
Medgenics Medical Israel Ltd.
ClinicalTrials.gov Identifier:
NCT01430000
First received: September 4, 2011
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.


Condition Intervention Phase
Hepatitis C
 Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medgenics Medical Israel Ltd.:

Primary Outcome Measures:
  • Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients using InfraDure Biopump [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment
    Subcutan implantation of autologus skin graft after ex-vivo treatment
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430000

Locations
Israel
Prof. Eithan Galun Gene Therapy Institute, Hadassah Medical Center Ein Kerem, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel, 91120
Contact: Eithan Galun, Professor     972-2-6777762     meitalc@hadassah.org.il    
Principal Investigator: Eithan Galun, Professor            
Sponsors and Collaborators
Medgenics Medical Israel Ltd.
Investigators
Principal Investigator: Eithan Galun, Professor No affiliation
  More Information

No publications provided

Responsible Party: Medgenics Medical Israel Ltd.
ClinicalTrials.gov Identifier: NCT01430000     History of Changes
Other Study ID Numbers: MG-002-01
Study First Received: September 4, 2011
Last Updated: September 6, 2011
Health Authority: Israel: Ministry of Health

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-2a
Interferon Alfa-2b
Interferons
 Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013