High ACE Activity Fresh Frozen Plasma for ACE Inhibitor Angioedema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Barnes-Jewish Hospital, Saint Louis, MOACE Inhibitor AngioedemaHigh ACE Activity Fresh Frozen Plasma - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new treatment for a life-threatening side effect of a widely-used class of drugs.

Eligible Conditions
  • ACE Inhibitor Angioedema

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Compare serum ACE activity before treatment and at 2 hours and 8 hours after treatment

Hour 8
Determine how treatment affects the severity of angioedema using a published validated clinical rating scale
Hour 2
The affect of treatment on bradykinin levels
Compare serum ACE activity before treatment and 30 minutes after treatment
Complement H50
Hour 8
Sustained change in serum ACE activity with treatment
Hour 2
The affect of treatment on substance P levels

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

High ACE Activity Fresh Frozen Plasma
1 of 2
Normal Saline
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: High ACE Activity Fresh Frozen Plasma · Has Placebo Group · Phase 2

High ACE Activity Fresh Frozen Plasma
Biological
Experimental Group · 1 Intervention: High ACE Activity Fresh Frozen Plasma · Intervention Types: Biological
Normal Saline
Other
PlaceboComparator Group · 1 Intervention: Normal Saline · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: compare serum ace activity before treatment and at 2 hours and 8 hours after treatment

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,284,080 Total Patients Enrolled
Steven J Weintraub, M.D.Principal InvestigatorWashington University School of Medicine and the St. Louis VA Medical Center

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Is the usage of High ACE Activity Fresh Frozen Plasma recognized by the FDA?

"The safety of High ACE Activity Fresh Frozen Plasma has been roughly evaluated as a 2, primarily because this is an exploratory Phase 2 trial that lacks evidence regarding efficacy but does have some background data affirming its security." - Anonymous Online Contributor

Unverified Answer

How many participants are currently enrolled in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial commenced on December 22nd 2020 and is actively recruiting patients after its most recent edit in October 24th 2022. The study is looking for 30 individuals at one medical site." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available for prospective patients in this experiment?

"According to clinicaltrials.gov, this research study is actively recruiting participants at the time of writing. The trial was initially posted on December 22nd 2020 and has had its details most recently revised on October 24th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.