Primary outcomeMean· within 4 days of study drug.
Biologic Effects by Coagulation Tests
| Group | Value (percentage of normal) | Spread |
|---|---|---|
| Neumega (Oprelveken, Interleukin 11) | 34.75 | 19.2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEfficacy and Safety of IL-11 in DDAVP Unresponsive
Short name IL-11DDAVP
NCTNCT00994929 (opens ClinicalTrials.gov in a new tab)Other idPRO08070154, Wyeth 3067K1-2214
This trial does not test a peptide that PepBank tracks.
- Measures Desmopressin, does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 9 participants (actual)
- Sponsor
- University of Pittsburgh · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Jan 2010
- Primary completion
- Apr 2012
- Completion
- Apr 2012
- First posted
- 14 Oct 2009 (estimated)
- Last update posted
- 2 Mar 2016 (estimated)
- Conditions
- Hemophilia A · Von Willebrand Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201120122013
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- Neumega (Oprelvekin, Interleukin 11, IL-11)Biological
Arms1
Experimental
Neumega (Oprelveken, Interleukin 11)
Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega
Primary outcomes1
Outcomes the sponsor listed as primary.
Biologic Effects by Coagulation Tests
Time frame · within 4 days of study drug.
Registry description
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 outcomes(2)
The Frequency of Adverse Events
Time frame · within 11 days of study drug
The Mechanism of Study Drug Effect by VWF mRNA.
Time frame · within 11 days of study drug.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeNumber· within 11 days of study drug
The Frequency of Adverse Events
| Group | Value (participants) |
|---|---|
| Neumega (Oprelveken, Interleukin 11) | 6 |
Secondary outcomeMean· within 11 days of study drug.
The Mechanism of Study Drug Effect by VWF mRNA.
| Group | Value (fold increase) |
|---|---|
| Neumega (Oprelveken, Interleukin 11) | 0.81 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Neumega (Oprelveken, Interleukin 11)Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion. | – | 0 / 9 | 6 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Clinical trial · 2013
Phase II prospective open-label trial of recombinant interleukin-11 in desmopressin-unresponsive von Willebrand disease and mild or moderate haemophilia A.
Ragni et al. 2013Thrombosis and haemostasiscited by 17
PMID 23238591PMC3689588DOI 10.1160/th12-06-0447PUB-23238591
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Males or females \>= 18 years of age.
* A diagnosis of hemophilia A, moderate (FVIII:C 0.01-0.04 U/ml) or mild (FVIII:C \>= 0.05 U/ml); or a diagnosis of VWD, defined by a low VWF:RCo and past bleeding history.
* For those with VWD, an inability to use DDAVP due to i) unresponsiveness defined as VWF:RCo or FVIII:C level lower than 50 IU/dl or less than a 3-fold increase after 0.3 microgram/kg DDAVP; ii) allergic reactions or seizures; or iii) a contraindication to DDAVP.
* Willingness to have blood drawn.
* Willingness to sign informed consent.
Exclusion Criteria:
* Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia.
* Use of immunomodulatory or experimental drugs, or diuretics.
* Pregnant or lactating women.
* Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis.
* Past allergic reaction to Neumega.
* Surgery within the past 8 weeks.
* Inability to comply with study protocol requirements.
* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study.
* Baseline safety and/or hematology lab values outside the normal limits and/or an EKG indicating an arrhythmia.
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