NCT00151125

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

September 6, 2005

Last Update Submit

May 16, 2016

Conditions

Von Willebrand Disease

Keywords

Von Willebrand DiseaseBleedingCoagulationHemostatic agent

Outcome Measures

Primary Outcomes (1)

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

    The time frame is up to 14 days per subject.

Secondary Outcomes (2)

  • The number and frequency of IL-11 associated adverse events.

    The time frame is up to 14 days per subject.

  • The mechanism of IL-11 biologic effect by VWFmRNA.

    The time frame is within 14 days per subject.

Study Arms (3)

A

EXPERIMENTAL

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

Drug: recombinant interleukin-11

B

EXPERIMENTAL

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

Drug: recombinant interleukin-11

C

EXPERIMENTAL

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

Drug: recombinant interleukin-11

Interventions

recombinant interleukin-11DRUG

25 mcg/kg subcutaneously daily for seven days

Also known as: rhIL-11, Neumega
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemophilia Center of Western Pennsylvania and General Clinical Research Center

Pittsburgh, Pennsylvania, 15213-4306, United States

Location

MeSH Terms

Conditions

von Willebrand DiseasesHemorrhageThrombosis

Interventions

Interleukin-11oprelvekin

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Margaret V. Ragni, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)