Trials / Unknown
UnknownNCT00004342
International Registry for Severe Chronic Neutropenia
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Timeline
- Start date
- 1994-06-01
- First posted
- 1999-10-19
- Last updated
- 2020-10-22
Locations
10 sites across 5 countries: United States, Australia, Canada, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT00004342. Inclusion in this directory is not an endorsement.