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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegasys | Drug | As prescribed |
| |
| Ribavirin |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure, pulse rate. | 6 and 12 months | |
| AEs, and laboratory parameters. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving correction of anemia | 3 months | |
| Percentage of patients not requiring blood transfusion | 12 months | |
| Course of Hb concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49933 | France | ||||
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| Drug |
As prescribed |
|
| epoetin beta [NeoRecormon] | Drug | 30,000 IU sc/week (starting dose) |
|
| 12 months |
| Percentage of patients maintaining initial ribavirin dose | 12 months |
| Besançon |
| 25030 |
| France |
| Caen | 14033 | France |
| Chambray-lès-Tours | 37171 | France |
| Clichy | 92118 | France |
| Créteil | 94000 | France |
| Créteil | 94010 | France |
| Limoges | 87042 | France |
| Lyon | 69437 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Montpellier | 34295 | France |
| Nice | 06202 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Pessac | 33604 | France |
| Rennes | 35033 | France |
| Rouen | 76031 | France |
| Saint-Laurent-du-Var | 06721 | France |
| Strasbourg | 67091 | France |
| Toulouse | 31059 | France |
| Tourcoing | 59208 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94804 | France |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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