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| ID | Type | Description | Link |
|---|---|---|---|
| HCG, No. Registry 505/05 | Registry Identifier | COFEPRIS, No. Registry 05330020020126 |
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| Name | Class |
|---|---|
| Cell Therapy And Technology, S.a. De C.v. | INDUSTRY |
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The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Experimental | Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years. |
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| Matched equivalent placebo | Placebo Comparator | Matched equivalent placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis staging | Fibrosis was evaluated according to Ishak fibrosis staging scale. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of necroinflammation activity | Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Armendariz-Borunda, Ph. D. | Head, Molecular Biology and Genomics Department | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25064094 | Derived | Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| Matched equivalent placebo | Drug |
|
| 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 |