The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study

Withdrawn before enrolling

Conditions studied: Chronic Hepatitis C, Chronic Hepatitis B

In brief

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 hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

Key facts

Study ID

NCT01831037

Run by

University of Arkansas

People needed

0

Starts

2015-07-01

Expected to finish

2019-12-01

Last updated by the study team

2015-01-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Calgary — Calgary, Alberta, Canada
• University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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