Clinical trial · Interventional
Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)
Long-term Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation: a Multicenter Study of Hepatocellular Carcinoma Prevention in Patients Non-responders to Combined Therapy With Alpha Interferon + Ribavirin or Peginterferon Alpha + Ribavirin or to Interferon Monotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis and initial signs of portal hypertension who did not respond to previous combined therapy with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa monotherapy and with a high proliferation rate before entering the study. The duration of treatment will be 3 years, and the follow-up period will be 2 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation (no treatment) | Other | — | UNRESOLVED |
| Peginterferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - PegIntron
- description
- Participants randomized to Arm A received peginterferon α-2b (PegIntron), 50 μg, weekly, subcutaneously (SC), for a period of 3 years.
- interventionNames
- Biological: Peginterferon alfa-2b
- type
- OTHER
- label
- Arm B - Control
- description
- Participants randomized to Arm B were under observation and received no treatment.
- interventionNames
- Other: Observation (no treatment)
Primary outcomes (1)
- measure
- Number of Participants With the Development of Hepatocellular Carcinoma (HCC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Cirrhotic participants, both sexes, Child Pugh A, B, HCV-RNA positive, age \< 70 years * Participants non-responders to IFN + Ribavirin or PegIFN + Ribavirin or IFN monotherapy * Pre-therapy liver biopsy (\< 36 months) with PCNA-LI \> 2.0 * Fibrosis score 5-6 (Ishak) * Initial portal hypertension, such as gastroesophageal varices or one of the following US sign: * Collateral circles * Spleen longitudinal diameter \> 12 cm * Portal vein diameter at hilus \> 12 mm * Portal flow \> 12 cm/sec * Participants must have the following minimum hematologic and biochemical criteria: * Hemoglobin \>= 11 g/dL * Granulocyte count \> 1,000/mm\^3 * Platelets \> 70,000/mm\^3 * Prothrombin activity \> 50% * Total bilirubin \<3 mg/dL * Albumin \>= 3.5 g/dL * Serum creatinine within normal limits * Uric Acid within normal limits * Thyroid Stimulating Hormone (TSH), within normal limits * Antinuclear antibodies (ANA) \< 1:160 * Written informed consent * Women of childbearing potential must have a negative pregnancy test * Acceptance of patients of both sexes of proper contraceptive measures for the study period Exclusion Criteria: * Pregnant or breast-feeding women * Co-infection with HIV and/or HBV * Autoimmune hepatitis or history of autoimmune disease * Alcoholic liver disease * Metabolic disease * HCC * Participants with liver and kidney transplants * Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy * Chronic renal failure or creatinine clearance \< 50 mL/min * Pre-existing thyroid disease unless it can be controlled with conventional treatment * History or presence of psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt * Epilepsy and/or compromised central nervous system (CNS) function * Significant cardiovascular dysfunction within the previous 6 months before the study starts (eg, angina, congestive heart failure, recent myocardial infarction, moderate or severe hypertension, significant arrhythmia) * Hemoglobinopathies * Poorly controlled diabetes mellitus * Chronic pulmonary disease (eg, chronic obstructive pulmonary disease) * Clinical gout * Hypersensitivity to interferons or any component of the drug
References
Publications (0)
Data not yet available