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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
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|ClinicalTrials.gov Identifier: NCT00048724|
Recruitment Status : Completed
First Posted : November 8, 2002
Results First Posted : June 11, 2009
Last Update Posted : April 4, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Cirrhosis||Biological: peginterferon alfa-2b (SCH 54031)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||631 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin|
|Study Start Date :||June 2002|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2008|
PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Biological: peginterferon alfa-2b (SCH 54031)
0.5 µg/kg subcutaneously once weekly for 60 months
Other Name: PegIntron
|No Intervention: Untreated Control|
Primary Outcome Measures :
- Time to Observation of the First Clinical Event Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]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
Secondary Outcome Measures :
- Time to Observation of the Disease Progression Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]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.
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