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NCT00994929 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of IL-11 in DDAVP Unresponsive
A Phase 2 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00994929 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 9 participants.
The verdict
NCT00994929, a Phase 2 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase of VWD coagulation tests (FVIII:C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers) to the normal range, or at least to 1.5-3 time baseline, following dosing of rhIL-11 when given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is not contraindicated. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Interventions
- BIOLOGICAL Neumega (Oprelvekin, Interleukin 11, IL-11)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00994929
The ClinicalTrials.gov registry entry for NCT00994929 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neumega (Oprelvekin, Interleukin 11, IL-11) is the first listed.
NCT00994929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00994929 about?
NCT00994929 is a clinical study titled "Efficacy and Safety of IL-11 in DDAVP Unresponsive". The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase of VWD coagulation tests...
What is the current status of trial NCT00994929?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00994929?
The interventions under investigation include: Neumega (Oprelvekin, Interleukin 11, IL-11) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00994929?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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