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

Medgenics Medical

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Hepatitis C

Treatments

Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01430000

MG-002-01

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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