Status:
COMPLETED
Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00759109
Start Date
March 1 2002
End Date
November 1 2009
Last Update
April 7 2017
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