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Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

2014-07-23 21:21:35 | BioPortfolio

Summary

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered according to the directions on the products' labeling). No administration of treatment is planned as a result of study enrollment.

Description

Patient enrollment will be sequential to avoid patient selection bias attributable to the investigator. Each site must enroll 7-8 patients to achieve the calculated sample size so that study objectives can be met.

Patients will be selected by the investigator during the last days of treatment with peginterferon alfa-2b plus ribavirin. Only those patients with a viral response at the end of treatment who sign the informed consent form are eligible.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Hepatitis C, Chronic

Intervention

Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)

Status

Active, not recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:21:35-0400

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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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