Status:
TERMINATED
Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients
Lead Sponsor:
Medgenics Medical Israel Ltd.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 aut...
Detailed Description
Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01433133
Start Date
October 1 2012
End Date
March 1 2014
Last Update
September 13 2016
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