Ignite Creation Date:
2024-05-06 @ 12:49 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01666249
Status:
SUSPENDED
Last Update Posted:
2022-11-02
First Post:
2012-07-25
Brief Title:
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk
Sponsor:
Azidus Brasil
Organization:
Azidus Brasil
Study Overview
Official Title:
Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D Panamerican in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk
Status:
SUSPENDED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended for indetermined period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a open prospective multicenter single-arm phase III study for clinical assessment of anti-Rh immunoglobulin KamRho-D in Rh and Coombs negative women with risk sensitization The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and neutralizes D antigen present in the Rh-positive fetal red blood cells Rh which passed into the bloodstream of Rh-negative pregnant women Rh
Detailed Description:
This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition child-birth and will be following until six months to verification of negative Coombs maintenance Safety evaluation data will include report of all adverse events including type frequency intensity seriousness severity and action taken related to the investigational product
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| Emenda 30 - 19092017 | OTHER | Azidus Brasil Pesquisa CientÃfica e Desenvolvimento Ltda | None |