drugset / Trial / NCT03997760

A Study of SHP655 (rADAMTS13) in Sickle Cell Disease

NCT03997760 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

TAK-755 (previously known as SHP655) is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of TAK-755 in SCD participants. Study participants will receive TAK-755 or placebo on Day 1. Their SCD will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be asked to follow-up on 13 days following SHP655 or placebo administration for safety assessment. Maximum duration of participation is expected to be about 2 months.

Timeline

Start
2019-10-21
Primary completion
2022-10-26
Completion
2022-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject TAK-755 Protein / enzyme biologic 40 iu/kg Intravenous
Subject TAK-755 Protein / enzyme biologic 80 iu/kg Intravenous
Subject TAK-755 Protein / enzyme biologic 160 iu/kg Intravenous

Indications