drugset / Trial / NCT02670720

Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

NCT02670720 ↗

Phase 3 Terminated 6 enrolled BioCryst Pharmaceuticals
NaSingle-groupOpen-labelPrevention

Summary

This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

Timeline

Start
2015-12
Primary completion
2016-02
Completion
2016-02

Outcome

Outcome not reported

Stopped: “preceding efficacy study of avoralstat in its current formulation was not significant and does not support continued development”

Drugs

EvaluationDrugModalityDoseRoute
Subject avoralstat Small molecule 500 mg Oral

Indications