A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
Phase 4
Completed
- Conditions
- Anemia
- Interventions
- Registration Number
- NCT00560274
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 epoetin beta [NeoRecormon] - 1 Pegasys - 1 Ribavirin -
- Primary Outcome Measures
Name Time Method Blood pressure, pulse rate. 6 and 12 months AEs, and laboratory parameters. Throughout study
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving correction of anemia 3 months Percentage of patients not requiring blood transfusion 12 months Course of Hb concentration 12 months Percentage of patients maintaining initial ribavirin dose 12 months