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Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (Study P02733AM4)(COMPLETED)

2014-08-27 03:27:28 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Carcinoma, Hepatocellular

Intervention

Peginterferon alfa-2b (SCH 054031), Observation (no treatment)

Status

Completed

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:28-0400

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Medical and Biotech [MESH] Definitions

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An ORTHOHEPADNAVIRUS causing chronic liver disease and hepatocellular carcinoma in woodchucks. It closely resembles the human hepatitis B virus.

A treatment method in which patients are under direct observation when they take their medication or receive their treatment. This method is designed to reduce the risk of treatment interruption and to ensure patient compliance.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

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