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Darbepoetin alfa

Anemia in Patients With a Non-Myeloid Malignancy

Ensayo de AMGEN INC en Neoplasias · Anemia.

Más ensayos de: Neoplasias · Anemia.

Fase

Fase 3

Estado

Completado

Participantes

707

previstos

Fin del objetivo primario

oct 2003

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ene 2002.

Qué mide

Tiempo hasta la primera respuesta de hemoglobina durante el periodo de tratamiento (during the treatment period) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroChemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

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Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00038064), actualizada en sep 2008.