Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004342
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
1999-10-18
Brief Title:
International Registry for Severe Chronic Neutropenia
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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 I Document the clinical course of severe chronic neutropenia SCN
II Monitor and assess long term safety of primary treatment in SCN patients in the United States Canada Europe and Australia
III Study the incidence and outcome of adverse events such as osteoporosis splenomegaly cytogenetic abnormalities myelodysplastic syndrome and leukemia
IV Evaluate growth and development and hematologic parameters V Monitor for clinically significant changes in primary treatment response over time
VI Establish a physician network to increase the understanding of SCN VII Establish a demographic database to allow for future research
II Monitor and assess long term safety of primary treatment in SCN patients in the United States Canada Europe and Australia
III Study the incidence and outcome of adverse events such as osteoporosis splenomegaly cytogenetic abnormalities myelodysplastic syndrome and leukemia
IV Evaluate growth and development and hematologic parameters V Monitor for clinically significant changes in primary treatment response over time
VI Establish a physician network to increase the understanding of SCN VII Establish a demographic database to allow for future research
Detailed Description:
PROTOCOL OUTLINE
Patients are treated by the referring physician as medically indicated Clinical data are collected at baseline and then every 6 months
Patients are treated by the referring physician as medically indicated Clinical data are collected at baseline and then every 6 months
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 |
|---|---|---|---|
| UW-730 | None | None | None |