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High-Dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

2014-07-23 21:35:14 | BioPortfolio

Summary

The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatitis C

Intervention

Peginterferon alfa-2a, Interferon alfa-2a, Ribavirin

Location

Erasmus Medical Center
Rotterdam
Netherlands
3015 CE

Status

Completed

Source

Foundation for Liver Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:14-0400

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Medical and Biotech [MESH] Definitions

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

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.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

A highly purified recombinant glycoprotein form of human THYROID-STIMULATING HORMONE, produced by recombinant DNA technology comprising two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary thyroid stimulating hormone.

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