IL-11 in Adults With Von Willebrand Disease Undergoing Surgery - Full Text View

Sponsor:	University of Pittsburgh
Collaborators:	University of North Carolina Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00524225

Purpose

The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

Condition	Intervention	Phase
Von Willebrand Disease	Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia MYH9-related disorder von Willebrand disease Help Me Understand Genetics

Drug Information available for: Oprelvekin

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

The primary efficacy outcome measure is perioperative estimated blood loss. [ Time Frame: The time frame is within 4 weeks of surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A secondary outcome measure is the mechanism of IL-11 effect by VWFmRNA. [ Time Frame: 4 weeks per subject ] [ Designated as safety issue: No ]
A secondary outcome measure is the frequency of IL-11 associated adverse events. [ Time Frame: The time frame is within 4 weeks of surgery. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure Other Name: Neumega (Oprelvekin, Interleukin 11, IL-11)

Detailed Description:

This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females 18 years of age and older
Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers
A past bleeding history
Responsive to DDAVP
Scheduled elective major surgery or major dental surgery at MUH or PUH
Willingness to have blood drawn

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 or those unwilling to use contraception during study
Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis
Past allergic reaction to Neumega or DDAVP
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
Past allergic reaction to Neumega or DDAVP
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524225

Contacts

Contact: Margaret V Ragni, MD, MPH	412-209-7288	ragni@dom.pitt.edu
Contact: Kristen Jaworski, RN	412-209-7411	kjaworski@itxm.org

Locations

United States, Pennsylvania
Hemophilia Center of Western PA	Recruiting
Pittsburgh, Pennsylvania, United States, 15213-4306
Contact: Margaret V Ragni, MD, MPH 412-209-7288 ragni@dom.pitt.edu
Contact: Kristen Jaworski, RN 412-209-7411 kjaworski@itxm.org
Principal Investigator: Margaret V Ragni, MD, MPH

Sponsors and Collaborators

University of Pittsburgh

University of North Carolina

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Principal Investigator:

Margaret V Ragni, MD, MPH

University of Pittsburgh

More Information

Publications:

Jankowitz RC, Nichols TC, Ragni MV. Recombinant IL-11 (Neumega, rhIL-11) increases plasma Von Willebrand Factor in Type 1 Von Willebrand Disease. Blood 108: 1003, 2006 (abstract).

Ragni MV, Jankowitz RC, Chapman HL, Merricks EP, Kloos MT, Dillow AM, Nichols TC. A phase II prospective open-label escalating dose trial of recombinant interleukin-11 in mild von Willebrand disease. Haemophilia. 2008 Sep;14(5):968-77. Epub 2008 Aug 1.

Responsible Party:	Margaret V. Ragni, MD, MPH, Principal Investigator, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00524225 History of Changes
Other Study ID Numbers:	PRO07030210
Study First Received:	August 31, 2007
Last Updated:	July 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

IL-11
von Willebrand disease
von Willebrand factor
VWFmRNA
surgery

Additional relevant MeSH terms:

Von Willebrand Diseases
Von Willebrand Disease, Type 1
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders

Hemorrhagic Disorders
Genetic Diseases, Inborn
Oprelvekin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012