Trial Outcomes & Findings for IL-11 in Adults With Von Willebrand Disease Undergoing Surgery (NCT NCT00524225)

NCT ID: NCT00524225

Last Updated: 2019-06-11

Results Overview

Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-06-11

Participant Flow

Participant milestones

Measure	Neumega (Interleukin 11, IL-11) Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Baseline characteristics by cohort

Measure	Neumega (Interleukin 11, IL-11) n=3 Participants Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.

Outcome measures

Measure	Neumega (Interleukin 11, IL-11) n=3 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Volume of Surgical Blood Loss	NA cc Volume of surgical blood loss was negligible for all participants.

PRIMARY outcome

Timeframe: 4 weeks

The volume of blood transfusion required (units of blood) after the surgical procedure.

Outcome measures

Measure	Neumega (Interleukin 11, IL-11) n=3 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Volume of Blood Transfusion	NA units of blood No participant had a transfusion.

SECONDARY outcome

Timeframe: 4 weeks per subject

Population: Even though three subjects were enrolled, none were assessed for VWFmRNA because the study stopped due to poor enrollment related to insurers requiring surgeries outside of UPMC.

The number of subjects with detectable VWFmRNA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The time frame is within 4 weeks of surgery.

mild headache, nausea

Outcome measures

Measure	Neumega (Interleukin 11, IL-11) n=3 Participants Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Number of Subjects Who Experienced Adverse Events Mild headache	1 participants
Number of Subjects Who Experienced Adverse Events nausea	1 participants

Adverse Events

Neumega (Interleukin 11, IL-11)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neumega (Interleukin 11, IL-11) n=3 participants at risk Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Nervous system disorders headache	33.3% 1/3 • Number of events 1
Gastrointestinal disorders nausea	33.3% 1/3 • Number of events 1

Additional Information

Dr. Margaret Ragni, Professor of Medicine

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