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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: Completed Phase 2 study, sponsored by University of Pittsburgh.
NCT00994929 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
VWF activity was measured by ristocetin-induced platelet agglutination using a Chronolog aggregometer11-14 and VWF:Ag by "sandwich" ELISA, using anti-VWF antibodies (DakoA082, Carpintera CA). Results were expressed in percent, with normal human plasma pool designated 100%, and severe type 3 VWD plasma used as the negative control
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 |
What the finished NCT00994929 record still lists
NCT00994929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Neumega (Oprelvekin, Interleukin 11, IL-11) is the first listed.
NCT00994929 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00994929's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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