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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

2014-07-23 21:51:58 | BioPortfolio

Summary

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatitis C, Chronic

Intervention

peginterferon alfa-2a [PEGASYS], Ribavirin

Location

Bakersfield
California
United States
93301

Status

Completed

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:51:58-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.

INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS in conjunction with HEPATITIS B VIRUS and lasting six months or more.

A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.

A defective virus, containing particles of RNA nucleoprotein in virion-like form, present in patients with acute hepatitis B and chronic hepatitis. It requires the presence of a hepadnavirus for full replication. This is the lone species in the genus Deltavirus.

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