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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Ribavirin; Drug: epoetin beta [NeoRecormon]; Drug: Pegasys

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560274

ML21362

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

190 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pegasys

Drug: Ribavirin

Drug: epoetin beta [NeoRecormon]