Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210977
Status:
WITHDRAWN
Last Update Posted:
2013-09-02
First Post:
2005-09-13
Brief Title:
A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study never started due to zero enrolment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the presence of anti erythropoietin antibodies anti EPO Ab in participants responding to any erythropoietin receptor agonist ERA therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy
Detailed Description:
This is an observational study in which the investigatorsphysicians observe the participants data and measure their outcomes international multicenter study conducted at multiple sites cohort group of individuals with similar characteristics study The study consists of prestudy phase observational phase 2 years and follow-up phase 1 year Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study In the observational phase participants erythropoietin antibody status positive or negative clinical progress treatment for anemia or prevention of anemia and outcome will be monitored During this study enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study Safety evaluations will include assessment of adverse events which will be monitored throughout the study The total duration of the study will be 3 years
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 |
|---|---|---|---|
| EPO-IMU-302 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |