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

NCT ID: NCT01430000

Last Updated: 2014-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

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

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Subcutan implantation of autologus skin graft after ex-vivo treatment

Subcutan implantation of autologus skin graft after ex-vivo treatment

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medgenics Medical Israel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eithan Galun, Professor

Role: PRINCIPAL_INVESTIGATOR

No affiliation

Locations

Prof. Eithan Galun Gene Therapy Institute, Hadassah Medical Center Ein Kerem, Jerusalem, Israel

Jerusalem, Jerusalem, Israel

Countries

Israel

Other Identifiers

MG-002-01

Identifier Type: -

Identifier Source: org_study_id