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The study was terminated due to low recruitment
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This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Beta 30000 IU | Experimental | Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Beta | Drug | Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Levels at 16 Weeks | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Iron Levels | 16 Weeks | |
| Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument | Up to 4 months | |
| Tolerability - Incidence of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caracas | 1060 | Venezuela | ||||
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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|
|
| Up to 4 months |
| Serum Transferrin Levels | 16 Weeks |
| Percentage of Participants With A Positive Response | 16 Weeks |
| Time To Global Response | Up to 4 months |
| Quality of Life In Relation to Anemia Grade | Up to 4 months |
| Serum Ferritin Levels | 16 Weeks |
| Valencia |
| 2001 |
| Venezuela |