Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 12:55 AM
Study NCT ID:
NCT01039350
Status:
TERMINATED
Last Update Posted:
2010-01-13
First Post:
2009-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
Sponsor:
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
Organization:
Study Overview
Official Title:
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
Status:
TERMINATED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was stopped due to a lack of recruitment after 48 patients included
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit.
Detailed Description:
This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit. Darbepoetin alfa will be initiated at a dose of 300 mcg QW SC over a period of 8 weeks. After 8 weeks, erythroid response will be evaluated, and treatment algorithm adapted to it.
The study treatment period will last for a maximum of 24 weeks. The treatment will end at the start of week 24. If the scheduled 24-week treatment period is not completed, it will end during the week of the last administration of the study drug.
The follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the last dose of darbepoetin alfa.
Subjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1 risk).
The study treatment period will last for a maximum of 24 weeks. The treatment will end at the start of week 24. If the scheduled 24-week treatment period is not completed, it will end during the week of the last administration of the study drug.
The follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the last dose of darbepoetin alfa.
Subjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1 risk).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2005-002414-38 | EUDRACT_NUMBER | None | View |