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

NCT00151125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-05-17

No results posted yet for this study

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

Conditions

  • Von Willebrand Disease

Interventions

DRUG

recombinant interleukin-11

25 mcg/kg subcutaneously daily for seven days

DRUG

recombinant interleukin-11

50 mcg/kg subcutaneously daily for 7 days

DRUG

recombinant interleukin-11

10 mcg/kg subcutaneously daily for 7 days

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • University of North Carolina

    collaborator OTHER
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Margaret V. Ragni, MD, MPH · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00151125 on ClinicalTrials.gov