Trial Outcomes & Findings for Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema (NCT NCT04679311)

Last Updated: 2024-03-27

Results Overview

The subjects' serum ACE activity will be assessed prior to treatment and 30 minutes after treatment and compared to determine if the treatment increases serum ACE activity

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Compare serum ACE activity before treatment and 30 minutes after treatment

Results posted on

2024-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	High ACE Activity Fresh Frozen Plasma Subjects will be treated with 2 units of fresh frozen plasma that have been preselected to contain ACE activity ≥50 U/L High ACE Activity Fresh Frozen Plasma: Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L	Normal Saline Subjects will be treated with normal saline 500 cc. Normal Saline: Subjects will be treated with normal saline 500 cc
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High ACE Activity Fresh Frozen Plasma Subjects will be treated with 2 units of fresh frozen plasma that have been preselected to contain ACE activity ≥50 U/L High ACE Activity Fresh Frozen Plasma: Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L	Normal Saline n=2 Participants Subjects will be treated with normal saline 500 cc. Normal Saline: Subjects will be treated with normal saline 500 cc	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	47.9 years n=7 Participants	47.9 years n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Compare serum ACE activity before treatment and 30 minutes after treatment

Population: Blood was never drawn due to pandemic related issues, the subjects' serum ACE activity were not assessed/drawn prior to treatment and nor 30 minutes after treatment, no result data available.

The subjects' serum ACE activity will be assessed prior to treatment and 30 minutes after treatment and compared to determine if the treatment increases serum ACE activity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Compare angioedema severity before treatment and 30 minutes, 2 hours, and 8 hours after treatment

Population: Due to pandemic related issues, no data was collected. Clinical rating scale was never done.

The severity of the the subjects' angioedema will be assessed using a published validated clinical rating scale before treatment and at 30 minutes, 2 hours, and 8 hours after treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Compare serum ACE activity before treatment and at 2 hours and 8 hours after treatment

Population: Due to pandemic related issues,sustained change in serum ACE activity with treatment was never collected.

Determine if treatment results in a sustained change in ACE activity levels

Outcome measures

Outcome data not reported

Adverse Events

High ACE Activity Fresh Frozen Plasma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Weintraub MD

Washington University School of Medicine

Phone: 314-652-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place