drugset / Trial / NCT04070326

A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children

NCT04070326

Phase 3 Completed 21 enrolled Shire
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab. Other aims are to learn if prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in children, how lanadelumab affects the child's body, and if the children develop antibodies to lanadelumab. The study doctors will treat acute HAE attacks according to their standard practice. Participants will receive lanadelumab for up to 52 weeks. When they start treatment, participants will visit their clinic every week for the first 4 weeks. Then, they will visit their clinic every 4 weeks during treatment.

Timeline

Start
2019-08-19
Primary completion
2021-10-30
Completion
2021-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanadelumab Monoclonal antibody 150 mg Subcutaneous

Indications