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Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM1)

2014-07-23 21:11:40 | BioPortfolio

Summary

This study involves treatment with boceprevir in combination with PegIntron (PEG2b) + ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 1. All subjects will begin treatment in the Pending Randomization Arm and will be treated with 4 weeks of PEG2b/RBV followed by 44 weeks of boceprevir plus PEG2b/RBV. Subjects will continue in the Pending Randomization Arm if their serum hemoglobin remains >10 g/dL throughout the 48 week treatment period. Subjects who become anemic (serum hemoglobin of approximately <=10 g/dL) within the 48-week treatment period will be randomized to Arm 1 (RBV dose reduction) or Arm 2 (erythropoietin use) for management of the anemia. The total duration of therapy for all subjects will be 48 weeks.

The primary objective of this trial is to compare the effect on efficacy of erythropoietin use versus RBV dose reduction for the management of anemia in subjects who become anemic during the treatment of CHC genotype 1 infection with boceprevir plus PEG2b/RBV therapy. It is suggested that an appropriate anemia management strategy may allow subjects to remain on optimal therapy and increase their ability to achieve SVR

Study Design

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

Conditions

Hepatitis C, Chronic

Intervention

Boceprevir (SCH 503034), erythropoietin, Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)

Location

Investigational Site 25
Mobile
Alabama
United States
36693

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:40-0400

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PubMed Articles [201 Associated PubMed Articles listed on BioPortfolio]

An easy-to-use baseline scoring system to predict response to peginterferon alfa-2a in patients with chronic hepatitis B in resource-limited settings.

Approximately one-third of patients have durable responses after finite (48-week) treatment with peginterferon alfa-2a. The ability to identify patients likely to respond would be particularly useful ...

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Editorial: a baseline tool for predicting response to peginterferon alfa-2a in HBeAg-positive patients-same score, different outcomes.

Editorial: a baseline tool for predicting response to peginterferon alfa-2a in HBeAg-positive patients-same score, different outcomes. Author's Reply.

Antiviral activity of Ribavirin nano-particles against measles virus.

Measles virus considers an important cause of child morbidity and mortality in some areas as Africa. Ribavirin's activity as a nucleoside analog can disclose the surprisingly broad spectrum action aga...

Medical and Biotech [MESH] Definitions

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 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.

Cell surface proteins that bind erythropoietin with high affinity and trigger intracellular changes influencing the behavior of cells.

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.

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