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

NCT00524342 | Completed Phase 2 Results DMC

• 2 other identifiers: PRO07040157Wyeth 102344
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Von Willebrand Disease

Keywords

IL-11; von Willebrand disease; von Willebrand factor; VWFmRNA; menorrhagia

Outcome Measures

Primary Outcomes (1)

• >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 Outcomes (2)

• No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).

  The time frame is up to 7 months per subject.

• No. of Subjects With IL-11 Associated Adverse Events.

  The time frame is up to 7 months per subject.

Study Arms (1)

Oprelvekin, Interleukin 11, IL-11

EXPERIMENTAL

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

Drug: Oprelvekin, Interleukin 11, IL-11

Interventions

Oprelvekin, Interleukin 11, IL-11 DRUG

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

Also known as: Neumega (Oprelvekin, Interleukin 11, IL-11)

Oprelvekin, Interleukin 11, IL-11

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Margaret Ragni: lead
• University of North Carolina: collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, 15213-4306, United States

Location

Related 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).

  BACKGROUND

• 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.

  PMID: 18680527 BACKGROUND

• 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: 10.1160/TH11-04-0274. Epub 2011 Aug 11.

  PMID: 21833452 RESULT

MeSH Terms

Conditions

von Willebrand Diseases; Menorrhagia

Interventions

oprelvekin; Interleukin-11

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Margaret Ragni
• Organization: University of Pittsburgh

ragni@dom.pitt.edu

412-209-7288

Study Officials

• Margaret V. Ragni, MD, MPH

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 31, 2018
• Results First Posted: November 7, 2014

Record last verified: 2018-01

Locations

US (1)