CLINICAL TRIALS PROFILE FOR EPOETIN ALFA
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Biosimilar Clinical Trials for epoetin alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01121237 ↗ | MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 | Completed | Hexal AG | 2010-02-01 | MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis. | |
| NCT01121237 ↗ | MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 | Completed | Sandoz | 2010-02-01 | MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis. | |
| NCT02140736 ↗ | Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology | Completed | Hospira, Inc. | 2009-09-01 | The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma. | |
| NCT02140736 ↗ | Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology | Completed | Hospira, now a wholly owned subsidiary of Pfizer | 2009-09-01 | The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma. | |
| NCT02341547 ↗ | Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure' | Unknown status | Penang Hospital, Malaysia | 2015-02-01 | This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following recruitment, a baseline data collection of full routine laboratory test before switch to Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes in continuous variables over time were evaluated using repeated-measures analysis of variance. Patients with iron-deficiency (ferritin <100 ng/ml or transferrin saturation <20%) will be analysed separately | |
| NCT02522975 ↗ | Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study) | Terminated | Ecron Acunova GmbH | Phase 4 | 2015-08-01 | This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet on haemodialysis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for epoetin alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00003681 ↗ | Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome | Unknown status | European Organisation for Research and Treatment of Cancer - EORTC | Phase 2 | 1998-08-01 | RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome. Epoetin alfa may stimulate red blood cell production and be an effective treatment for anemia in patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine with or without epoetin alfa in treating patients who have myelodysplastic syndrome. |
| NCT00004917 ↗ | Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer | Completed | National Cancer Institute (NCI) | Phase 3 | 2000-06-01 | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer. |
| NCT00004917 ↗ | Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer | Completed | Radiation Therapy Oncology Group | Phase 3 | 2000-06-01 | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer. |
| NCT00006136 ↗ | Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia | Completed | Boston University | Phase 2 | 1999-03-01 | OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia. II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate with improved hematologic response in these patients when treated with this regimen. III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels correlates with improved hematologic response in these patients when treated with this regimen. IV. Determine whether any particular genotypes are more responsive than others to this therapy in these patients. V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic response in these patients when treated with this regimen. |
| NCT00014222 ↗ | Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer | Completed | Cancer and Leukemia Group B | Phase 3 | 2000-12-04 | RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer. |
| NCT00014222 ↗ | Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer | Completed | North Central Cancer Treatment Group | Phase 3 | 2000-12-04 | RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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