The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
631
0.5 µg/kg subcutaneously once weekly for 60 months
Time to Observation of the First Clinical Event Experienced by a Subject
Clinical events are liver decompensation \[variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites\], hepatic carcinoma, death, and/or liver transplantation
Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Time to Observation of the Disease Progression Experienced by a Subject
Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.
Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
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