NCT00262379

Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

Detailed description

Show that the correction of anemia by epoetin beta (NeoRecormon®) able to maintain a optimal dose of ribavirin (Copegus®). The study compares two therapeutic strategies : use or non-use of epoetin beta (NeoRecormon®) in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a (Pegasys®) plus ribavirin (Copegus®). The main judgement criteria are : * Sustained Viral Response (Week 72) * Viral Response at the End of Treatment (Week 48) * Quality of life * Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods * Clinical and biological tolerance

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	epoetin beta (NeoRecormon®)	• Prescription of the epoetin beta : when blood concentration of hemoglobin is lower or equal to 12 g/dL in male or lower or equal to 11 g/dL in female

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2005-12-06
• Last updated: 2014-12-12

Locations

37 sites across 1 country: France