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| ID | Type | Description | Link |
|---|---|---|---|
| ANRS HC16 Gammatri |
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| Name | Class |
|---|---|
| InterMune | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients
Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin for 24 Weeks. In many patients, there is no efficacy of this treatment on hepatitis C, and there is no treatment recommended for them. Interferon gamma has anti-infectious and anti-fibrosis activity. This study will evaluate the effect, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks, of the addition of interferon gamma in non responders patients. 65 patients will be included in order to include 27 patients who are non responders after 12 weeks of a second treatment and are eligible to receive interferon gamma. Patients will then receive peg-interferon alpha 2a (180 micro g once a week, by injection), ribavirin (1,000 to 1,200 mg per day, according to weight) and interferon gamma (100 micro g thrice a week, by injection) during 8 months
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-interferon alpha 2a (drug) | Drug | |||
| Ribavirin (drug) | Drug | |||
| Interferon gamma (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure) |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response at W72 | ||
| Biochemical response at W72 (ALT below normal value) | ||
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Couzigou, MD, PhD | Hôpital du Haut-Lévêque, Pessac, France | Principal Investigator |
| Geneviève Chêne, MD, PhD | INSERM U593, Bordeaux, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie | Pessac | 33604 | France | |||
| Hôpital du Haut-Levêque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23190183 | Derived | Couzigou P, Perusat S, Bourliere M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chene G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060. |
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| Immunologic response (CD4 and CD8 HCV specific) |
| Safety |
| Pessac |
| 33604 |
| France |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D012254 | Ribavirin |
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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