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

Primary Purpose

Von Willebrand Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interleukin-11
recombinant interleukin-11
recombinant interleukin-11
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Von Willebrand Disease focused on measuring Von Willebrand Disease, Bleeding, Coagulation, Hemostatic agent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hemophilia Center of Western Pennsylvania and General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A

B

C

Arm Description

rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days

rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days

rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days

Outcomes

Primary Outcome Measures

The number and percent increase of VWD coagulation tests after seven daily doses of rhIL-11, boosted by DDAVP day 7.

Secondary Outcome Measures

The number and frequency of IL-11 associated adverse events.
The mechanism of IL-11 biologic effect by VWFmRNA.

Full Information

First Posted
September 6, 2005
Last Updated
May 16, 2016
Sponsor
University of Pittsburgh
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, University of North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00151125
Brief Title
Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
Official Title
Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, University of North Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal if rhIL-11 and DDAVP together will boost VWF levels even higher the onset, peak, and duration of rhIL-11 effect 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: age >= 18 years of age 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: to compare the hemostatic efficacy of three escalating doses of rhIL-11 to determine the biologic effects of rhIL-11 to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Von Willebrand Disease
Keywords
Von Willebrand Disease, Bleeding, Coagulation, Hemostatic agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
Arm Title
B
Arm Type
Experimental
Arm Description
rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
Arm Title
C
Arm Type
Experimental
Arm Description
rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-11
Other Intervention Name(s)
rhIL-11, Neumega
Intervention Description
25 mcg/kg subcutaneously daily for seven days
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-11
Other Intervention Name(s)
rhIL-11, Neumega
Intervention Description
50 mcg/kg subcutaneously daily for 7 days
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-11
Other Intervention Name(s)
rhIL-11, Neumega
Intervention Description
10 mcg/kg subcutaneously daily for 7 days
Primary Outcome Measure Information:
Title
The number and percent increase of VWD coagulation tests after seven daily doses of rhIL-11, boosted by DDAVP day 7.
Time Frame
The time frame is up to 14 days per subject.
Secondary Outcome Measure Information:
Title
The number and frequency of IL-11 associated adverse events.
Time Frame
The time frame is up to 14 days per subject.
Title
The mechanism of IL-11 biologic effect by VWFmRNA.
Time Frame
The time frame is within 14 days per subject.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret V. Ragni, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hemophilia Center of Western Pennsylvania and General Clinical Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-4306
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicalresearch.pitt.edu
Description
Bleeding Disorders, Von Willebrand Disease

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

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