Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212862
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2005-09-13
Brief Title:
Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
Dosing and Outcomes Study of Erythropoietic Stimulating Therapies
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOSE
Brief Summary:
The purpose of this study is to describe patient characteristics treatment patterns and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy EST
Detailed Description:
The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies DOSE is a prospective observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST eg epoetin alfa or darbepoetin alfa The planned duration of the DOSE Registry is three years Based on initial results the registry sponsor may elect to extend the duration of the registryThis study does not specify treatment protocols require any particular assignment of patients to treatment protocols or in any other way require participating physicians to alter their practice patterns Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment but to submit information on baseline patient characteristics treatment patterns and clinical outcomes Baseline determinations will include patient demographics tumor and treatment type hematologic parameters and patient reported outcomes Data will be collected over the 16-week study period with regard to EST treatment hematologic outcomes and patient reported outcomes
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ABT-OP-03-02 | OTHER | Ortho Biotech Products LP | None |