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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.

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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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