EAP for Deucrictibant Immediate-release
ConditionHereditary Angioedema
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age12-75
SponsorPharvaris Netherlands B.V.
About this trial
This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as determined by their treating physician.
Eligibility criteria
Qualifiers
Provision of informed consent: Participants must provide written informed consent. Adolescents (≥12 to <18 years old, or as per local law) require consent of parent or legally designated representative/guardian and must assent. If an adolescent reaches adulthood during the EAP, they must sign the adult informed consent form (ICF) to remain in the EAP.
Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
Confirmed diagnosis of HAE.
for participants with hereditary angioedema with normal C1 inhibitor (HAE-nC1INH): documented genetic mutation associated with HAE-nC1INH
Disqualifiers
Pregnancy or nursing: any female participant who is pregnant, planning to become pregnant during the EAP, or currently breastfeeding.
Any diagnosis of angioedema other than HAE.
Significant comorbidity: any clinically significant comorbidity or systemic dysfunction (e.g., cardiovascular, gastrointestinal, renal, neurologic, respiratory) that, in the opinion of the treating physician, would interfere with the participant's safety or ability to participate in this EAP.
Severe hepatic impairment (Child-Pugh Class C).
Trial design
Treatments tested in this trial
- Deucrictibant IR
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov