Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients

NCT01433133 | Terminated Phase 1

• 1 other identifier: MG-002-02
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Viral Load: incidence of sustained virologic response (SVR)

  Viral load to be measured along the study expecting notable decrease in the viral load by week 24 post intervention

  24 weeks

Secondary Outcomes (4)

• Rapid virologic response (RVR)

  Time Frame-Study Week 4

• Early virologic response (EVR)

  Time Frame-Study week 12

• End-of-treatment response (EOT)

  Time Frame-Study week 48, 104

• Rapid virologic response (RVR)

  Evaluation after 4 weeks from treatment day 0

Study Arms (1)

1

EXPERIMENTAL

• Genotype 3 chronic HCV with detectable serum HCV RNA

Biological: implantation

Interventions

implantation BIOLOGICAL

subcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

MeSH Terms

Conditions

Hepatitis C

Interventions

Drug Implants

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

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

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 5, 2011
• First Posted: September 13, 2011
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share