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

An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy

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.

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.