NCT00151125

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

Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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: 1. age \>= 18 years of age 2. 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: 1. to compare the hemostatic efficacy of three escalating doses of rhIL-11 2. to determine the biologic effects of rhIL-11 3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11 4. 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.

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-08
• Last updated: 2016-05-17

Locations

1 site across 1 country: United States