Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
The study is a first in man, dose escalation study that will measure the safety and efficacy
of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5
dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects will
be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending on the
dose level, the next set of subjects will be dosed. The study drug is a gene therapy
treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected cells.
Once the study drug is given, it cannot be withdrawn. Additionally, once an individual
receives a dose, he or she will not be able to receive a second dose, but will remain
eligible to receive most other HCV treatments.