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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00148421 |
Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: Darbepoetin alfa and Epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy. |
The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030125 |
Study First Received: | June 30, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00148421 |
Health Authority: | United States: Institutional Review Board |
Non-myeloid malignancy Chemotherapy-induced anemia |
Epoetin Alfa Hematologic Diseases Darbepoetin alfa Anemia |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |