Immunotherapy With TG4040 in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus
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|ClinicalTrials.gov Identifier: NCT00529321|
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 3, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Biological: MVA-HCV (Immunotherapy)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2010|
- Biological: MVA-HCV (Immunotherapy)
- Safety (adverse events, vital signs, physical examination, standard laboratory tests) [ Time Frame: regularly ]
- Virology (quantification of HCV-RNA), immunology (cellular-mediated and humoral immune responses) [ Time Frame: regularly ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529321
|Hôpital Henri Mondor|
|Créteil, France, 94010|
|Hopital A. Michallon|
|La Tronche, France, 38700|
|Hopital de l'Hotel-Dieu|
|Lyon, France, 69288|
|Hôpital de l'Hôtel Dieu|
|Nantes, France, 44000|
|Strasbourg, France, 67091|
|Hôpital de Brabois|
|Vandoeuvre, France, 54500|
|Principal Investigator:||Christian TREPO, MD||Hopital de l'Hotel-Dieu|