Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004801
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-01
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:
OBJECTIVES
Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency
Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency
Detailed Description:
PROTOCOL OUTLINE
Patients receive monoclonal factor IX replacement therapy as inpatients Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home
Patients receive monoclonal factor IX replacement therapy as inpatients Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-621 | None | None | None |