NL-OMON49723
Completed
Phase 2
A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema - ISIS 721744-CS2
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Documented diagnosis of HAE\-1/HAE\-2 (for inclusion in Part A) or HAE\-nC1\-INH
- •(for inclusion in Part B);
- •\- Participants must experience a minimum of 2 HAE attacks (assessed by the
- •Angioedema Activity Score \[AAS] and confirmed by the investigator) during the
- •screening period;
- •\- Access to, and the ability to use, 1 or more acute medication(s) to treat
- •angioedema attacks.
Exclusion Criteria
- •\- Anticipated use of short\-term prophylaxis for angioedema attacks for a
- •pre\-planned procedure during the Screening or Study Periods.
- •\- Concurrent diagnosis of any other type of recurrent angioedema, including
- •acquired or idiopathic angioedema.
- •\- History of acquired coagulopathies or bleeding diathesis.
- •\- Active infection with human immunodeficiency virus (HIV), hepatitis C or
- •chronic hepatitis B.
- •\- Malignancy within 5 years, except for basal or squamous cell carcinoma of the
- •skin or carcinoma in situ of the cervix that has been successfully treated.
- •\- Treatment with another investigational drug or biological agent within 1
Outcomes
Primary Outcomes
Not specified
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