Status:
WITHDRAWN
The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
University of North Carolina, Chapel Hill
University of Toronto
Conditions:
Chronic Hepatitis C
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Brief Summary
This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB) experiencing regression of liver cirrhosis after effective antiviral therapy have decreased risk for hepatocellu...
Detailed Description
Cirrhosis is the final pathway of chronic liver disease, and up to 30% of patients develop hepatocellular carcinoma (HCC) within 5 years of diagnosis of cirrhosis. Worldwide, chronic hepatitis C (CHC)...
Eligibility Criteria
Inclusion
- Age 18-70
- Chronic liver disease due to CHC or CHB.
- Starting of disease-specific treatment no earlier than January of 2010. Treatment could consist of:
- combination therapy with peginterferon and ribavirin, with or without a direct-acting viral agent in CHC;
- single or combination therapy containing peginterferon, entecavir, or tenofovir in CHB.
- Established cirrhosis on liver biopsy (METAVIR F4) obtained before starting disease-specific treatment.
- In patients without liver biopsy, any of the following criteria will be used as a surrogate to define cirrhosis:
- History of spleen \>13 cm, bilirubin \>2, albumin \<3.5, INR \>1.5 (2 of 3 criteria).
- History of APRI (\[AST/ULN\]/platelets x 100) \>2, and esophageal varices or ascites.
- History of Fibrotest/Fibrosure \>0.74, and TE \>12.5 kPa (M-probe) or \>10 kPa (XL-probe).
Exclusion
- Known diagnosis of hepatocellular carcinoma or portal vein thrombosis
- Conditions limiting Fibrotest/Fibrosure read: hemolysis, Gilbert's syndrome, autoimmune disease.
- Conditions limiting TE read: ascites, heart failure with retrograde vascular congestion, extrahepatic cholestasis.
- Pregnancy or implantable active medical device (such as pacemaker or defibrillator).
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01831037
Start Date
July 1 2015
End Date
December 1 2019
Last Update
January 28 2015
Active Locations (4)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72211
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
4
University of Toronto
Toronto, Ontario, Canada, M5T 2S8