Clinical trial · Observational
The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study
NCT01831037CI-TRIAL-00016725ROLFHwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to obtain funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Hepatitis B | — | UNRESOLVED | — |
| Chronic Hepatitis C | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regression of fibrosis | Other | — | UNRESOLVED |
| Specific risk factors related to hepatocellular carcinoma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Regression of fibrosis
- description
- Group conformed by patients experiencing improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.
- interventionNames
- Other: Regression of fibrosis
- Other: Specific risk factors related to hepatocellular carcinoma
- label
- No regression of fibrosis
- description
- Group conformed by patients not showing the predefined improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.
Primary outcomes (1)
- measure
- Hepatocellular carcinoma
- timeFrame
- 3 years
- description
- According to standard imaging surveillance protocol, and confirmatory CT/MRI/biopsy
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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).
References
Publications (8)
- BACKGROUNDEl-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061. PMID 22537432
- BACKGROUNDBruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available. PMID 21374666
- BACKGROUNDEuropean Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available. PMID 22424438
- BACKGROUNDBarritt AS 4th, Fried MW. Maximizing opportunities and avoiding mistakes in triple therapy for hepatitis C virus. Gastroenterology. 2012 May;142(6):1314-1323.e1. doi: 10.1053/j.gastro.2012.02.013. PMID 22537438
- BACKGROUNDvan der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, Duarte-Rojo A, Heathcote EJ, Manns MP, Kuske L, Zeuzem S, Hofmann WP, de Knegt RJ, Hansen BE, Janssen HL. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012 Dec 26;308(24):2584-93. doi: 10.1001/jama.2012.144878. PMID 23268517
- BACKGROUNDDuarte-Rojo A, Altamirano JT, Feld JJ. Noninvasive markers of fibrosis: key concepts for improving accuracy in daily clinical practice. Ann Hepatol. 2012 Jul-Aug;11(4):426-39. PMID 22700624
- BACKGROUNDMyers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Duarte-Rojo A, Wong D, Beaton M, Levstik M, Crotty P, Elkashab M. Feasibility and diagnostic performance of the FibroScan XL probe for liver stiffness measurement in overweight and obese patients. Hepatology. 2012 Jan;55(1):199-208. doi: 10.1002/hep.24624. Epub 2011 Nov 18.