Anemia
Conditions
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.
Interventions
DRUGPegasys
As prescribed
DRUGRibavirin
As prescribed
30,000 IU sc/week (starting dose)
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure, pulse rate. | 6 and 12 months |
| AEs, and laboratory parameters. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed