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The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.
This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cases | Patients treated with direct-acting antivirals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a progression of liver injury. | To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response. | Development of hepatic decompensation, defined as a patient with ascites, spontaneous bacterial peritonitis (PBR), digestive bleeding of varicose origin, or hepatic encephalopathy at some point in the evolution from SVR until the end of study follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population are patients with chronic hepatitis C who have been treated with direct-acting antivirals between 2014 and 2017. Also patients with fibrosis and liver cirrhosis.
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| Name | Affiliation | Role |
|---|---|---|
| Paula Fernández Álvarez | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen macarena | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Up to 4 weeks. |
| Rate of risk factors presented by patients. | Identify risk factors in patients who develop liver complications after achieving sustained viral response. | Up to 4 weeks. |
| Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications. | To determine if there is a relationship between the absence of improvement in non-invasive fibrosis parameters and the development of liver complications. | Up to 4 weeks. |
| Clinical and fibrosis data. | To compare the clinical and fibrosis data between patients who develop liver complications and those who do not. | Up to 4 weeks. |
| 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 |