Status:
UNKNOWN
Incidence of de Novo Hepatocellular Carcinoma After Antiviral Agents for HCV.
Lead Sponsor:
Austral University, Argentina
Conditions:
Hepatitis C
Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
The main risk factor for development of hepatocellular carcinoma (HCC) is cirrhosis of any etiology, with an annual incidence risk between 1-6%; currently the leading cause of death in patients with c...
Detailed Description
Name of the study: INCIDENCE OF HEPATOCELLULAR CARCINOMA IN CIRRHOTIC PATIENTS WITH HEPATITIS C INFECTION, TRETAED WITH DIRECT ANTIVIRAL AGENTS IN LATIN AMERICA: A MULTICENTER PROSPECTIVE COHORT STUD...
Eligibility Criteria
Inclusion
- Signed Informed Consent (CI) obtained prior to any study specific procedure. Patients should be able to understand written informed and be ready to sign it (ANNEX I).
- Men and women 18 years or older.
- Clinical, histological or non-invasive diagnosis of cirrhosis, according to the American Association for the Study of Liver Diseases, AASLD criteria) \[15\].
- Child Pugh A or B (ANNEX II). Child Pugh classification should be calculated based on clinical findings and laboratory results during the selection period.
- Chronic Hepatitis C, defined as positive viremia with real time PCR method.
- Current or prior treatment with DAA, including any interferon-free scheme, either in a clinical protocol or treated in the daily practice.
- Co-infection with HIV infection is allowed or Hepatitis B.
Exclusion
- • Prior diagnosis of Hepatocellular to treatment with DAA.
- Previous liver transplantation.
- Drug addiction, medical, psychological or social problems that may interfere with the patient's participation in the study or evaluation of the results.
- Pregnancy and/or breastfeeding.
- Close relationship with the research center; eg close family member of the researcher, dependent (eg employee or student research center that could access study records and data CRF).
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT03775798
Start Date
May 1 2016
End Date
January 1 2021
Last Update
December 19 2018
Active Locations (1)
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1
Universidad Austral
Pilar, Buenos Aires, Argentina, 1629