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Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.
The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silybin + vitamin E + phospholipids complex | Active Comparator | Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months |
|
| sugar pill | Placebo Comparator | one placebo pill per day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| transforming growth factor beta | serum marker of liver fibrosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| hyaluronic acid | serum marker of liver fibrosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| metalloproteinase 2 | serum marker of liver fibrosis | 12 months |
| amino-terminal pro-peptide of type III procollagen | serum marker of liver fibrosis |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cannizzaro Hospital | Catania | Sicily | 95125 | Italy |
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| Drug |
|
| 12 months |
| tissue inhibitor of matrix metalloproteinase type I | serum marker of liver fibrosis | 12 months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077385 | Silybin |
| D014810 | Vitamin E |
| D010743 | Phospholipids |
| ID | Term |
|---|---|
| D012838 | Silymarin |
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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