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The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.
Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain.
In all these patients the following parameters will be assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan: Liver and Spleen elastography | Device | In cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR). | 6 months | |
| Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (Composite outcome including survival free of all cause of death, liver transplantation, decompensation and/or increase in >1 point in Child Pugh score). | 12 months |
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Inclusion Criteria:
Age 18 to 90 years.
History of chronic hepatitis C infection.
Compensated advanced chronic liver disease (Baveno VI definition):
Indication to start antiviral treatment with new oral drugs.
Willingness to enter the study.
Sign the informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Genescà Ferrer, PhD MD | Hospital Universitari Vall d'hebron Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| 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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