IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia

Von Willebrand Disease Clinical Trial

Official title:

Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524342
• Other study ID #: PRO07040157
• Secondary ID: Wyeth 102344
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: January 5, 2018
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

Description:

This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete this study. All aspects of this study, including the rhIL-11 injections and the screening, hemostatic and safety monitoring, and coagulation testing, are considered experimental. The specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to determine the mechanism of the hemostatic response of rhIL-11.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Females 18-45 years of age

• Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers

• Menorrhagia refractory to estrogens, hormones, hemostatic agents

• Willingness to have blood drawn

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Menorrhagia
• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

Drug:
• Oprelvekin, Interleukin 11, IL-11
25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles

Locations

Country	Name	City	State
United States	Hemophilia Center of Western PA	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Margaret Ragni	University of North Carolina, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. doi: 10.1111/j.1365-2516.2008.01827.x. Epub 2008 Aug 1. — View Citation

Ragni MV, Jankowitz RC, Jaworski K, Merricks EP, Kloos MT, Nichols TC. Phase II prospective open-label trial of recombinant interleukin-11 in women with mild von Willebrand disease and refractory menorrhagia. Thromb Haemost. 2011 Oct;106(4):641-5. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months	Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.	6 months
Secondary	No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).	No. of subjects with detectable VWFmRNA, a measure of IL-11 (interleukin-11) function, specifically increasing VWF synthesis.	The time frame is up to 7 months per subject.
Secondary	No. of Subjects With IL-11 Associated Adverse Events.	The number of subjects with IL-11 associated adverse events.	The time frame is up to 7 months per subject.