Phase II Study of IL-11 (Neumega) in Von Willebrand Disease

NCT00151125

Last updated date
Study Location
Hemophilia Center of Western Pennsylvania and General Clinical Research Center
Pittsburgh, Pennsylvania, 15213-4306, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Von Willebrand Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males and females 18 years of age or older

- Confirmed VWD by 2 of 4 VWD coagulation tests abnormal

- A past bleeding history

- No hormone, oral contraceptive, estrogen use in past 8 weeks

- Willingness to have blood drawn

- Willingness to sign informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia


- Use of estrogens, hormones, oral contraceptives in past 8 weeks


- Use of immunomodulatory or experimental drugs or diuretics


- Pregnant or lactating women


- Past 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 FVIII, VWF within 5 days of study

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Von Willebrand DiseaseIL-11 in Adults With Von Willebrand Disease Undergoing Surgery
NCT00524225
  1. Pittsburgh, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Von Willebrand DiseasePhase II Study of IL-11 (Neumega) in Von Willebrand Disease
NCT00151125
  1. Pittsburgh, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
Official Title  ICMJE Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease
Brief Summary

This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:

  1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal
  2. if rhIL-11 and DDAVP together will boost VWF levels even higher
  3. the onset, peak, and duration of rhIL-11 effect
  4. if rhIL-11 is safe in individuals with Von Willebrand Disease
Detailed Description

This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD).

The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease.

Study subjects will include the following subjects:

  1. age >= 18 years of age
  2. diagnosis of VWD confirmed by: 2a) at least 2 of 4 abnormal vWD-related coagulation tests; 2b) a past bleeding history

A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are:

  1. to compare the hemostatic efficacy of three escalating doses of rhIL-11
  2. to determine the biologic effects of rhIL-11
  3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11
  4. to compare the safety of three escalating doses of rhIL-11

Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline.

Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema.

The study will last up to 4 weeks per subject, and for 24 months for the entire study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Von Willebrand Disease
Intervention  ICMJE
  • Drug: recombinant interleukin-11
    25 mcg/kg subcutaneously daily for seven days
    Other Name: rhIL-11, Neumega
  • Drug: recombinant interleukin-11
    50 mcg/kg subcutaneously daily for 7 days
    Other Name: rhIL-11, Neumega
  • Drug: recombinant interleukin-11
    10 mcg/kg subcutaneously daily for 7 days
    Other Name: rhIL-11, Neumega
Study Arms  ICMJE
  • Experimental: A
    rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
  • Experimental: B
    rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
  • Experimental: C
    rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2008)
12
Original Enrollment  ICMJE
 (submitted: September 6, 2005)
9
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 18 years of age or older
  • Confirmed VWD by 2 of 4 VWD coagulation tests abnormal
  • A past bleeding history
  • No hormone, oral contraceptive, estrogen use in past 8 weeks
  • Willingness to have blood drawn
  • Willingness to sign informed consent

Exclusion Criteria:

  • Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia
  • Use of estrogens, hormones, oral contraceptives in past 8 weeks
  • Use of immunomodulatory or experimental drugs or diuretics
  • Pregnant or lactating women
  • Past 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 FVIII, VWF within 5 days of study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151125
Other Study ID Numbers  ICMJE 0403006
0403006 ( Other Identifier: protocol id )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret Ragni, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • University of North Carolina
Investigators  ICMJE
Principal Investigator:Margaret V. Ragni, MD, MPHUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP