Efficacy and Safety of IL-11 in DDAVP Unresponsive

Completed · Phase 2

Conditions studied: Hemophilia A, Von Willebrand Disease

In brief

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.

Key facts

Study ID

NCT00994929

Run by

University of Pittsburgh

People needed

9

Starts

2010-01-01

Expected to finish

2012-04-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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