| Trial ID: | L1516 |
| Source ID: | NCT02522975
|
| Associated Drug: |
Epiao®
|
| Title: |
Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)
|
| Acronym: |
BEAT_001
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Anaemia
|
| Interventions: |
DRUG: EPIAO®|DRUG: EPREX®
|
| Outcome Measures: |
Primary: Mean absolute change in haemoglobin(Hb), Mean absolute change in haemoglobin(Hb) level from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (g/dl),respectively.", 24 weeks | Secondary: Mean absolute change in weekly epoetin dosage, Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (IU/kg/week)., 24 weeks|Frequency of adverse events, To observe the frequency of adverse events following EPIAO® and EPREX® administration., 52 weeks|Occurence of anti-epoetin antibodies, To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy., 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. | Collaborators: Navitas Life Sciences GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2019-08
|
| Results First Posted: |
|
| Last Update Posted: |
2020-10-22
|
| Locations: |
Bamrasnaradura Infectious Disease Institute, Bangkok, 10700, Thailand|Bhumibol Adulyadej hospital, Bangkok, 10700, Thailand|BMA hospital, Bangkok, 10700, Thailand|Chulalongkorn King Memorial hospital, Bangkok, 10700, Thailand|Klongton Hospital, Bangkok, 10700, Thailand|Phramongkutklao hospital, Bangkok, 10700, Thailand|Rajavithi hospital, Bangkok, 10700, Thailand|Siriraj Hospital, Bangkok, 10700, Thailand
|
| URL: |
https://clinicaltrials.gov/show/NCT02522975
|
