Trial Outcomes & Findings for IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia (NCT NCT00524342)

NCT ID: NCT00524342

Last Updated: 2018-01-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-01-31

Participant Flow

Participant milestones

Measure	IL-11 Neumega (Oprelvekin, Interleukin 11, IL-11): 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
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	IL-11 n=7 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	IL-11 n=7 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 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
>50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months	71 percentage of participants

SECONDARY outcome

Timeframe: The time frame is up to 7 months per subject.

No. of subjects with detectable VWFmRNA, a measure of IL-11 (interleukin-11) function, specifically increasing VWF synthesis.

Outcome measures

Measure	IL-11 n=7 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 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
No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).	7 participants

SECONDARY outcome

Timeframe: The time frame is up to 7 months per subject.

The number of subjects with IL-11 associated adverse events.

Outcome measures

Measure	IL-11 n=7 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 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
No. of Subjects With IL-11 Associated Adverse Events. fluid retention	6 participants
No. of Subjects With IL-11 Associated Adverse Events. injection site bruising	6 participants
No. of Subjects With IL-11 Associated Adverse Events. flushing	3 participants

Adverse Events

IL-11

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IL-11 n=7 participants at risk Neumega (Oprelvekin, Interleukin 11, IL-11): 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
Skin and subcutaneous tissue disorders conjunctival erythema	100.0% 7/7 • up to 7 months
General disorders fluid retention	85.7% 6/7 • up to 7 months
General disorders injection site bruising	85.7% 6/7 • up to 7 months
General disorders flushing	42.9% 3/7 • up to 7 months
Blood and lymphatic system disorders thrombocytosis	14.3% 1/7 • up to 7 months
Renal and urinary disorders hypokalemia	14.3% 1/7 • up to 7 months
Renal and urinary disorders diastolic hypertension	14.3% 1/7 • up to 7 months

Additional Information

Dr. Margaret Ragni

University of Pittsburgh

Phone: 412-209-7288

Email: ragni@dom.pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place