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Sponsored by: |
Transgene |
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Information provided by: | Transgene |
ClinicalTrials.gov Identifier: | NCT00529321 |
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 | Intervention | Phase |
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Hepatitis C, Chronic |
Biological: MVA-HCV (Immunotherapy) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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) |
Estimated Enrollment: | 42 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have compensated liver disease, with:
Laboratory tests values:
Additionnal cohorts:
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
Serious, concomitant disorder, including:
France | |
Hopital de l'Hotel-Dieu | Active, not recruiting |
LYON, France, 69288 | |
Hopital A. Michallon | Active, not recruiting |
La Tronche, France, 38700 | |
Hopital Civil | Active, not recruiting |
Strasbourg, France, 67091 | |
Hôpital de Brabois | Recruiting |
Vandoeuvre, France, 54500 | |
Contact: JP Bronowicki, Pr jp.bronowicki@chu-nancy.fr | |
Principal Investigator: JP Bronowicki, Pr |
Principal Investigator: | Christian TREPO, MD | Hopital de l'Hotel-Dieu |
Responsible Party: | Transgene ( Transgene ) |
Study ID Numbers: | TG4040.01 |
Study First Received: | September 7, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00529321 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections |