Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema

Ionis Pharmaceuticals

Status

Conditions: Hereditary Angioedema

Treatments: Drug: Donidalorsen

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06415448

ISIS 721744-E01

Details and patient eligibility

About

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.

Full description

The Expanded Access Program (EAP) is intended to provide pre-approval access to donidalorsen for eligible patients with HAE who complete the ISIS 721744-CS3 clinical trial.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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• Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of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.