Phase 3 N=150 Randomized Prevention

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

Carcinoma, Hepatocellular

Bottom Line

View on ClinicalTrials.gov: NCT00759109 ↗

Enrolled (actual)

150

Serious AEs

44.0%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With the Development of Hepatocellular Carcinoma (HCC) — 15; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Peginterferon alfa-2b (Biological); Observation (no treatment) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With the Development of Hepatocellular Carcinoma (HCC)	15; 11	—
SECONDARY Number of Participants With Development of Hepatic Decompensation	4; 9	—
SECONDARY Survival Time of Participants	5.2840; 4.0602	—
SECONDARY Number of Patients With a Virological Response Rate	0; 0; 3; 0; 1; 0	—
SECONDARY Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)	-2.0; -0.9	—

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.

Eligibility Criteria

Inclusion Criteria

Cirrhotic participants, both sexes, Child Pugh A, B, HCV-RNA positive, age 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 = 3.5 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00759109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.