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BCX7353 for Hereditary Angioedema (APeX-S Trial)

Phase 2 & 3
Waitlist Available
Led By Henriette Farkas, MD
Research Sponsored by BioCryst Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks.
Access to appropriate medication for treatment of acute attacks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks (us) / 216 weeks (row)
Awards & highlights

APeX-S Trial Summary

This trial is testing a drug to see if it can prevent angioedema attacks in people with HAE.

Eligible Conditions
  • Hereditary Angioedema
  • Prophylaxis

APeX-S Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

APeX-S Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks (us) / 216 weeks (row)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks (us) / 216 weeks (row) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety & Tolerability
Secondary outcome measures
Incidence of Acute Attacks of Angioedema in Subjects During Treatment
Patient Reported Quality of Life (QoL) During Treatment
Patient's Satisfaction With Medication During Long Term Administration of Berotralstat
+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 387 Patients • NCT03472040
33%
Nasopharyngitis
23%
Headache
14%
Diarrhoea
14%
Abdominal pain
14%
Upper respiratory tract infection
11%
Hereditary angioedema
10%
Sinusitis
10%
Gastroenteritis
10%
Oropharyngeal pain
10%
Abdominal pain upper
10%
COVID-19
9%
Nausea
8%
Gastrooesophageal reflux disease
8%
Influenza
7%
Urinary tract infection
6%
Abdominal discomfort
5%
Dyspepsia
3%
Vomiting
2%
Pneumonia
2%
Medical observation
2%
Abortion spontaneous
2%
Enteritis
1%
Gastroenteritis viral
1%
Lower limb fracture
1%
Radius fracture
1%
Anal abscess
1%
Gingivitis
1%
Hepatic enzyme increased
1%
Myocardial infarction
1%
Asthma
1%
Facial paralysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
110 mg Followed by 150 mg Berotralstat
150 mg Berotralstat

APeX-S Trial Design

1Treatment groups
Experimental Treatment
Group I: BCX7353 150 mg once dailyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berotralstat
FDA approved

Find a Location

Who is running the clinical trial?

BioCryst PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,100 Total Patients Enrolled
Henriette Farkas, MDPrincipal InvestigatorSemmelweis University, Budapest, Hungary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most similar treatments to BCX7353 that have been studied in the past?

"BCX7353 was first studied in 2018 at Study Center. Since that time, there have been 6 completed studies with 3 more presently active. A significant number of these studies originate from Marietta, Georgia."

Answered by AI

Are there any available openings for people who want to participate in this clinical trial?

"The clinical trial was posted on 2018-02-16 and was last edited on 2020-12-15, which indicates that the study is no longer recruiting participants. Although this trial is not seeking candidates anymore, there are 32 other studies presently accepting participants right now."

Answered by AI

Where is this research being conducted?

"Right now, 42 hospitals and medical facilities are enrolling patients for this clinical trial. While the sites in Marietta, Hershey and Indianapolis are the closest to the original research locations, participating sites are located across the country to make enrolling more convenient for patients."

Answered by AI

Has this research been done before?

"BCX7353 clinical trials began in 2018 with the first study being completed that same year. 121 patients were involved in the initial Phase 1 trial sponsored by BioCryst Pharmaceuticals. The success of this first trial led to the approval of BCX7353 as a Phase 3 drug. Presently, there are 3 active trials involving BCX7353 taking place in 51 different cities and 23 unique countries."

Answered by AI
~55 spots leftby Mar 2025