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

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University of Pittsburgh

Status and phase

Completed
Phase 2

Conditions

Von Willebrand Disease

Treatments

Drug: recombinant interleukin-11

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00151125
0403006 (Other Identifier)

Details and patient eligibility

About

This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate: if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal if rhIL-11 and DDAVP together will boost VWF levels even higher the onset, peak, and duration of rhIL-11 effect if rhIL-11 is safe in individuals with Von Willebrand Disease

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 3 patient groups

A
Experimental group
Description:
rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
Treatment:
Drug: recombinant interleukin-11
B
Experimental group
Description:
rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
Treatment:
Drug: recombinant interleukin-11
C
Experimental group
Description:
rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
Treatment:
Drug: recombinant interleukin-11

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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