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| Name | Class |
|---|---|
| Centro de Investigación Médica Aplicada (CIMA) | UNKNOWN |
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Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Autologous dendritic cells transduced with Ad encoding NS3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cells transduced with Ad encoding NS3 | Biological | Patients will receive 3 different dosis of the vaccine via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound. | Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on viral load and immune response | 6 months |
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Inclusion Criteria:
Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment
Exclusion Criteria:
Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency
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| 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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