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Date: 2010-07-12
Phase: II
Anouncement: Launch
Biotech: Transgene (France)
Pharma:
Product: TG4040 (MVA-HCV, MVA virus carrying and expressing non structural proteins (NS3, NS4 et NS5B) of the hepatitis C virus)
Disease: Hepatitis C
Country: Europe, USA and Israel
Other: Transgene has announced the opening of the first clinical site for the phase II trial of TG4040 (MVA-HCV) for the treatment of naïve genotype 1 hepatitis C infected patients in combination with standard of care (Pegylated-Interferon Alpha and Ribavarin).
This phase II trial has been named HCVac and this randomized, open-label, multi-site, international study will enrol140 patients chronically infected with HCV genotype 1 and who have not been previously treated for their infection.
Forty clinical sites across seven countries in Europe, the United States and Israel will participate in the study.

HCVac has three arms: one control arm using standard of care alone and two experimental arms evaluating TG4040 at two different schedules of administration in combination with standard of care. In both experimental arms, TG4040 will be administered by subcutaneous injection at a dose of 107 pfu. The schedule of administration will consist of 6 injections in the first arm and 13 for the second arm.

The primary objective of HCVac is to evaluate the efficacy of TG4040, in combination with standard of care, as measured by the proportion of patients who achieve complete Early Virologic Response (cEVR). cEVR is defined as HCV RNA (ribonucleic acid) which is undetectable after 12 weeks of treatment.

The secondary objectives of the trial are: determine the effects on viral load over-time and up to 24 weeks after stopping therapy; determine the immunogenicity of TG4040 and identify molecular biomarkers related to TG4040 efficacy in combination with standard of
care.

First results of the HCVac clinical trial are expected around the third quarter of 2011.