Hepatitis C, Chronic Clinical Trial
Official title:
Open-label, Dose-escalating, Phase I Study of TG4040 (MVA-HCV) in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus (HCV Genotype 1)
The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040
in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).
Patients will be sequentially treated at an escalting dose of TG4040. All patients will be
followed up to at least 6 months after his/her first injection. In addition, all patients
treated at the highest dose will receive a TG4040 boost injection 6 months after the first
injection, and will be followed up during an additional 6-month period.
The first nine patients will be sequentially treated in three cohorts of three patients,
i.e. they will receive 3 SC injections of TG4040 on Days 1, 8 and 15, at the dose of 10e6
pfu (first cohort), 10e7 pfu (second cohort), or 10e8 pfu (third cohort).
There will be a one-week safety interval between the first injection of the patients of a
given cohort, and a two-week safety interval between the last injection of the last patient
of a given cohort and the first injection of the first patient of the next one. There will
be also a two-week safety observation period after the last injection of the last patient of
the third cohort. If the dose of 10e8 pfu does not raise safety problems, then 6 patients
will be further enrolled, without safety intervals between patients. They will receive 3 SC
injections of TG4040 at the dose of 10e8 pfu, on Days 1, 8 and 15.
All patients will be followed up to at least 6 months after his/her first injection. In
addition, all patients treated at the dose of 10e8 pfu will receive a TG4040 boost injection
6 months after the first injection, and will be followed up during an additional 6-month
period.
Three additional cohorts of 9 patients will receive a boost injection either at 2, 4 or 6
months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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