IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

This study has been terminated.
(Recruitment slow as single center conducting in rare disease)
Sponsor:
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00524225
First received: August 31, 2007
Last updated: June 5, 2014
Last verified: June 2014
  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 2

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:


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 ]

Enrollment: 3
Study Start Date: February 2008
Study Completion Date: June 2012
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213-4306
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).

Responsible Party: Margaret Ragni, Laurel Yasko, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00524225     History of Changes
Other Study ID Numbers: PRO07030210
Study First Received: August 31, 2007
Last Updated: June 5, 2014
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 Disease, Type 1
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Oprelvekin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014