A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic hepatitis C;

• quantifiable serum HCV RNA;

• Pegylated interferon + ribavirin treatment started <6 months before study;

• Hb <10g/dL.

Exclusion Criteria:

• treatment with ESA during preceding 12 weeks;

• poorly controlled hypertension;

• history of cancer, except for basal cell cancer and cervical cancer in situ.