NCT01585324

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg subcutaneously weekly
DRUG	ribavirin [Copegus]	1000 mg or 1200 mg orally daily

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-04-25
• Last updated: 2015-07-24
• Results posted: 2015-07-24

Locations

1 site across 1 country: Czechia