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Last Updated: January 25, 2021

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CLINICAL TRIALS PROFILE FOR EPOETIN ALFA

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Biosimilar Clinical Trials for epoetin alfa

This table shows clinical trials for biosimilars. See the next table for all clinical trials
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 N/A 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 N/A 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. N/A 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' Not yet recruiting Penang Hospital, Malaysia N/A 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) Recruiting 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.
NCT02522975 Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study) Recruiting Shenyang Sunshine Pharmaceutical Co., LTD. 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.
NCT02947438 Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) Recruiting Ecron Acunova GmbH Phase 4 2015-12-01 This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.
>Trial ID >Title >Status >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 2000-12-01 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 2000-12-01 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 Southwest Oncology Group Phase 3 2000-12-01 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 >Phase >Start Date >Summary

Clinical Trial Conditions for epoetin alfa

Condition Name

Condition Name for epoetin alfa
Intervention Trials
Anemia 183
Chronic Kidney Disease 15
Myelodysplastic Syndromes 13
Neoplasms 11
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Condition MeSH

Condition MeSH for epoetin alfa
Intervention Trials
Anemia 164
Renal Insufficiency, Chronic 64
Kidney Diseases 56
Renal Insufficiency 31
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Clinical Trial Locations for epoetin alfa

Trials by Country

Trials by Country for epoetin alfa
Location Trials
United States 828
Canada 66
Italy 51
Spain 43
France 40
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Trials by US State

Trials by US State for epoetin alfa
Location Trials
California 50
Texas 42
Florida 41
New York 36
Pennsylvania 33
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Clinical Trial Progress for epoetin alfa

Clinical Trial Phase

Clinical Trial Phase for epoetin alfa
Clinical Trial Phase Trials
Phase 4 66
Phase 3 117
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for epoetin alfa
Clinical Trial Phase Trials
Completed 197
Terminated 44
Recruiting 22
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Clinical Trial Sponsors for epoetin alfa

Sponsor Name

Sponsor Name for epoetin alfa
Sponsor Trials
Hoffmann-La Roche 73
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 58
Ortho Biotech Products, L.P. 30
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Sponsor Type

Sponsor Type for epoetin alfa
Sponsor Trials
Industry 295
Other 131
NIH 14
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