Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00718692
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2008-07-18
Brief Title:
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura ITP
Sponsor:
Symphogen AS
Organization:
Symphogen AS
Study Overview
Official Title:
A Multi-centre Single Intravenous Dose Exploratory Dose-finding Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura ITP in RhD Positive Non-splenectomized Adult Subjects
Status:
COMPLETED
Status Verified Date:
2019-01
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:
This trial is designed as a multi-centre single-dose exploratory dose-finding open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts Subjects will receive a single IV dose of Sym001
Detailed Description:
None
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 |
|---|---|---|---|
| 2007-006081-15 | EUDRACT_NUMBER | None | None |