82
Participants
Start Date
November 7, 2019
Primary Completion Date
May 15, 2021
Study Completion Date
January 28, 2022
Recombinant Human Erythropoietin Alpha
This study consisted of a screening period (4 weeks), titration period (4\~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection
Recombinant Human Erythropoietin Alpha
This study consisted of a screening period (4 weeks), titration period (4\~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection
Gatot Soebroto Army Hospital, Jakarta
Collaborators (1)
Equilab International
UNKNOWN
PT. Daewoong Infion
INDUSTRY