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

NCT01430000 | Withdrawn Phase 1 DMC

• 1 other identifier: MG-002-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

  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

  9 months

Interventions

Subcutan implantation of autologus skin graft after ex-vivo treatment BIOLOGICAL

Subcutan implantation of autologus skin graft after ex-vivo treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medgenics Medical Israel Ltd.: lead

Study Sites (1)

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

Jerusalem, Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Eithan Galun, Professor

  No affiliation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2011
• First Posted: September 7, 2011
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

IL (1)