NCT01055821

Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients

A Phase II Randomized, Multicenter, Open-label Study of TG4040 (MVA-HCV) in Combination With Pegylated Interferon Alfa-2a and Ribavirin Versus Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naïve Patients With Chronic Genotype 1 Hepatitis C.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Transgene · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this protocol is to study the effect of the standard of care in hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	pegylated interferon and ribavirin	48 weeks
BIOLOGICAL	TG4040 + SOC	6 injections
BIOLOGICAL	TG4040 + SOC	13 injections

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-10-01
• Completion: 2013-08-01
• First posted: 2010-01-26
• Last updated: 2013-08-13

Locations

1 site across 1 country: Germany