Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)

NCT ID: NCT00759109

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2009-11-30

Brief Summary

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

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A - PegIntron

Participants randomized to Arm A received peginterferon α-2b (PegIntron), 50 μg, weekly, subcutaneously (SC), for a period of 3 years.

Group Type: EXPERIMENTAL

Peginterferon alfa-2b

Intervention Type: BIOLOGICAL

Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years.

Arm B - Control

Participants randomized to Arm B were under observation and received no treatment.

Group Type: OTHER

Observation (no treatment)

Intervention Type: OTHER

No treatment was given to participants enrolled in the control arm (Arm B).

Interventions

Peginterferon alfa-2b

Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years.

Intervention Type: BIOLOGICAL

Observation (no treatment)

No treatment was given to participants enrolled in the control arm (Arm B).

Intervention Type: OTHER

Other Intervention Names

PegIntron; Pegylated Alfa-2b; SCH 054031

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P02733

Identifier Type: -

Identifier Source: org_study_id