Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01128881
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2010-05-07
Brief Title:
IMMUNINE Pre-Treatment Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
IMMUNINE - Purified Factor IX Concentrate Virus-Inactivated A Phase 4 Prospective Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients With Severe FIX Level 1 or Moderately Severe FIX Level 2 Hemophilia B Who Are Planned to Enter BAX 326 Study 250901 to Investigate a New Recombinant FIX Concentrate
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The primary objective of this study is to prospectively document the exposure to IMMUNINE and to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while receiving prophylactic treatment in up to 50 previously treated patients PTPs aged 12-64 years and approximately 20 pediatric PTPs up to 11 years of age with severe FIX level 1 or moderately severe FIX level 2 hemophilia B who are planned to enter BAX326 study 250901 provided all eligibility criteria are met
In addition this study will evaluate the efficacy safety immunogenicity thrombogenicity and health-related quality of life HR QoL of these subjects
In addition this study will evaluate the efficacy safety immunogenicity thrombogenicity and health-related quality of life HR QoL of these subjects
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 |
|---|---|---|---|
| 2009-016719-39 | EUDRACT_NUMBER | None | None |