Trial · NCT00994929
Efficacy and Safety of IL-11 in DDAVP Unresponsive
NCT00994929, Phase 2, Completed, University of Pittsburgh; results first posted 2016-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of IL-11 in DDAVP Unresponsive. Trials, record NCT00994929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00994929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of IL-11 in DDAVP Unresponsive
- NCT number
- NCT00994929
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Hemophilia A, Von Willebrand Disease
- Interventions
- Neumega (Oprelvekin, Interleukin 11, IL-11)
- First posted
- 2009-10-14
- Last updated
- 2016-03-02
- Results first posted
- 2016-03-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biologic Effects by Coagulation Tests | within 4 days of study drug. | 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 |
| Secondary | The Frequency of Adverse Events | within 11 days of study drug | |
| Secondary | The Mechanism of Study Drug Effect by VWF mRNA. | within 11 days of study drug. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Biologic Effects by Coagulation Tests | within 4 days of study drug. | Four subjects had VWD and five subjects had mild hemophilia A | percentage of normal | MEAN |
| SECONDARY | The Frequency of Adverse Events | within 11 days of study drug | participants | NUMBER | |
| SECONDARY | The Mechanism of Study Drug Effect by VWF mRNA. | within 11 days of study drug. | fold increase | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Biologic Effects by Coagulation Tests | Neumega (Oprelveken, Interleukin 11) | VWD patients | 34.75 | Standard Error 19.2 | percentage of normal |
| Biologic Effects by Coagulation Tests | Neumega (Oprelveken, Interleukin 11) | Mild hemophilia A patients | 143.4 | Standard Error 18.6 | percentage of normal |
| The Frequency of Adverse Events | Neumega (Oprelveken, Interleukin 11) | 6 | participants | ||
| The Mechanism of Study Drug Effect by VWF mRNA. | Neumega (Oprelveken, Interleukin 11) | 0.81 | Full Range -0.07 to 2.65 | fold increase |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neumega (Oprelveken, Interleukin 11) | 9 | |
| Overall Study | COMPLETED | Neumega (Oprelveken, Interleukin 11) | 9 | |
| Overall Study | NOT COMPLETED | Neumega (Oprelveken, Interleukin 11) | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival Infection | Eye disorders | Neumega (Oprelveken, Interleukin 11) | 6 | 9 | 6 |
| other | Dyspepsia | Gastrointestinal disorders | Neumega (Oprelveken, Interleukin 11) | 3 | 9 | 3 |
| other | Fluid Retention | General disorders | Neumega (Oprelveken, Interleukin 11) | 2 | 9 | 2 |
| other | Flu-Like Symptoms | General disorders | Neumega (Oprelveken, Interleukin 11) | 2 | 9 | 2 |
| other | Headache | General disorders | Neumega (Oprelveken, Interleukin 11) | 2 | 9 | 2 |
| other | Injection Site Erythema | General disorders | Neumega (Oprelveken, Interleukin 11) | 2 | 9 | 2 |
| other | Lightheadedness | General disorders | Neumega (Oprelveken, Interleukin 11) | 1 | 9 | 1 |
| other | Flushing | General disorders | Neumega (Oprelveken, Interleukin 11) | 1 | 9 | 1 |
| other | Insomnia | General disorders | Neumega (Oprelveken, Interleukin 11) | 1 | 9 | 1 |
| other | Drowsiness | General disorders | Neumega (Oprelveken, Interleukin 11) | 1 | 9 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neumega (Oprelveken, Interleukin 11) | ||
| Total, other adverse events | Neumega (Oprelveken, Interleukin 11) | 6 | 9 |
| Total, serious adverse events | Neumega (Oprelveken, Interleukin 11) | 0 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00994929
GET https://conductscience.org/api/trials/v1/NCT00994929/registered