Status:
COMPLETED
Long Term Follow-up of Hepatitis C Cured Patients
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Chronic Hepatitis C
Chronic Liver Disease
Eligibility:
All Genders
18-85 years
Brief Summary
Objectives: The general objective of the present project is to gain a better understanding of disease outcome in cACLD patients treated with the new oral DAA. In particular, the project will focus on...
Detailed Description
HYPOTHESIS: \- The prognosis of cACLD patients who achieve SVR will improve during follow-up and this will be reflected in an improvement in liver and spleen stiffness and reduction of liver-related ...
Eligibility Criteria
Inclusion
- Patients having suggestive or highly suggestive cACLD defined as LSM 10-15 kPa or LSM ≥15 kPa, respectively. Patients with suggestive cACLD (LSM 10-15 kPa) will be divided in two subgroups depending on the presence of at least one of the following: gastroesophageal varices, hepatic venous pressure gradient (HVPG) \>5 mmHg, nodular liver or collateral circulation in US, splenomegaly (\>=13 cm) or platelet count \<150,000. Patients with suggestive cACLD (LSM 10-15 kPa) and none of the prior characteristics will form the subgroup of occult cACLD.
- Age between 18-85 years old.
- SVR after antiviral therapy.
- Signed informed consent.
Exclusion
- History of liver decompensation.
- Hepatitis B virus coinfection.
- HIV infection.
- Prior liver transplantation.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03246048
Start Date
January 1 2016
End Date
June 1 2021
Last Update
September 21 2022
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