Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
ConditionHereditary Angioedema
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorIonis Pharmaceuticals, Inc.
About this trial
The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients in the ISIS 721744-CS3 (Open-Label Extension [OLE] Study) who have completed 205 weeks of treatment.
Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity.
Disqualifiers
Any patient who is pregnant or plans to become pregnant.
Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.
Trial design
Treatments tested in this trial
Donidalorsen
DrugDonidalorsen administered once monthly or every other month by subcutaneous (SC) injections in the abdomen, thigh, or upper arm.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov