Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT00484094
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2007-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Investigating Rapamune For Post-Marketing Surveillance
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
Status:
COMPLETED
Status Verified Date:
2016-11
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:
None
Brief Summary:
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:
1. Unknown adverse reactions, especially serious adverse reactions
2. To assess the incidence of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug (e.g., proteinuria)
4. Factors that may affect the effectiveness of the drug
1. Unknown adverse reactions, especially serious adverse reactions
2. To assess the incidence of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug (e.g., proteinuria)
4. Factors that may affect the effectiveness of the drug
Detailed Description:
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
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 |
|---|---|---|---|---|
| B1741015 | OTHER | Alias Study Number | View |