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5 Diseases |  |
2 Trials |
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2 Trials |  |
20 News |  |
- |||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Trial completion date, Trial primary completion date: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - Jul 14, 2024
P3, N=429, Recruiting, Sponsor: Genexine, Inc.
Trial completion date: Apr 2027 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Dec 2026
- || HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
New P1 trial: Clinical Trial of Efepoetin Alfa in Healthy Subjects (clinicaltrials.gov) - Jul 7, 2024
P1, N=40, Not yet recruiting, Sponsor: Genexine, Inc.
- |||||||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
New P3 trial: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - Jun 20, 2024
P3, N=429, Recruiting, Sponsor: Genexine, Inc.
- ||||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Trial completion, Trial completion date: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - Dec 22, 2023
P3, N=391, Completed, Sponsor: PT Kalbe Genexine Biologics
Trial completion date: Apr 2027 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Dec 2026 Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Jun 2023
- Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, Epogen (epoetin alfa) / Amgen, HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
OPEN LABEL, NON-INFERIORITY, RANDOMIZED, ACTIVE-CONTROLLED, PHASE III CLINICAL STUDY OF EPOETIN ALFA VERSUS METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA FOR TREATMENT OF ANAEMIA IN CKD NON-DIALYSIS PATIENT () - Mar 28, 2023 - Abstract #ISNWCN2023ISN_WCN_935;
A total of 322 adverse events (AE) in 99 patients (69.7%) in Epoetin Alfa group and 264 AE in 91 patients (64.5%) in Methoxy Polyethylene Glycol-Epoetin Beta group. Conclusions Based on this study, the interim data indicates that the Epoetin Alfa and Methoxy Polyethylene Glycol-Epoetin Beta have comparable efficacy and safety profiles for anaemia in CKD-non-dialysis patients.
- ||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Enrollment closed, Trial completion date, Trial primary completion date: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - Sep 26, 2022
P3, N=391, Active, not recruiting, Sponsor: PT Kalbe Genexine Biologics
Conclusions Based on this study, the interim data indicates that the Epoetin Alfa and Methoxy Polyethylene Glycol-Epoetin Beta have comparable efficacy and safety profiles for anaemia in CKD-non-dialysis patients. Unknown status --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Jul 2023
- |||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Enrollment open, Trial initiation date: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - Sep 16, 2020
P3, N=386, Recruiting, Sponsor: PT Kalbe Genexine Biologics
Unknown status --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Jul 2023 Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Jul 2020
- |||||||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
New P3 trial: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - Nov 14, 2019
P3, N=386, Not yet recruiting, Sponsor: PT Kalbe Genexine Biologics
- |||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Trial completion, Trial initiation date: Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Oct 16, 2017
P2, N=257, Completed, Sponsor: Genexine, Inc.
Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Jul 2020 Active, not recruiting --> Completed | Initiation date: Aug 2014 --> Apr 2014
- ||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Enrollment closed, Trial primary completion date: Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Apr 27, 2017
P2, N=252, Active, not recruiting, Sponsor: Genexine, Inc.
Active, not recruiting --> Completed | Initiation date: Aug 2014 --> Apr 2014 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2015 --> Apr 2017
- |||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Enrollment open, Trial initiation date: Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Feb 3, 2015
P2, N=250, Recruiting, Sponsor: Genexine, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2015 --> Apr 2017 Not yet recruiting --> Recruiting | Initiation date: Mar 2014 --> Jul 2014
- HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Trial completion: GX-E2-P1: Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects (clinicaltrials.gov) - Jan 29, 2015
P1, N=10, Completed, Sponsor: Genexine, Inc.
Not yet recruiting --> Recruiting | Initiation date: Mar 2014 --> Jul 2014 Not yet recruiting --> Completed
- HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
New P1 trial: GX-E2-P1: Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects (clinicaltrials.gov) - Nov 17, 2014
P1, N=10, Not yet recruiting, Sponsor: Genexine, Inc.
- ||||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
New P2 trial: Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Jan 22, 2014
P2, N=250, Not yet recruiting, Sponsor: Genexine, Inc.
- ||| HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Trial completion: To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin (clinicaltrials.gov) - Jul 16, 2012
P1, N=100, Completed, Sponsor: Green Cross Corporation
Not yet recruiting --> Completed Active, not recruiting --> Completed