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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00994929 |
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Date of registration:
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12/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of IL-11 in DDAVP Unresponsive
IL-11DDAVP |
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Scientific title:
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Phase II Biologic Effects Study of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Moderate or Mild Hemophilia A, or Von Willebrand Disease Unable to Use DDAVP |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00994929 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Margaret V. Ragni, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hemophilia A
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Von Willebrand Disease
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Intervention(s)
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Biological: Neumega (Oprelvekin, Interleukin 11, IL-11)
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Primary Outcome(s)
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Biologic Effects by Coagulation Tests
[Time Frame: within 4 days of study drug.]
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Secondary Outcome(s)
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The Frequency of Adverse Events
[Time Frame: within 11 days of study drug]
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The Mechanism of Study Drug Effect by VWF mRNA.
[Time Frame: within 11 days of study drug.]
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Secondary ID(s)
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PRO08070154, Wyeth 3067K1-2214
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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