drugset / Trial / NCT04394286

A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects

NCT04394286 ↗

Phase 1/2 Terminated 2 enrolled Baxalta now part of Shire
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and dose escalation of SHP648 an adeno-associated viral vector for gene transfer in hemophilia B participants.

Timeline

Start
2020-05-13
Primary completion
2021-05-03
Completion
2021-05-03

Outcome

Outcome not reported

Stopped: “Takeda has decided to not further develop the SHP648 (TAK-748) program. No subjects have been dosed with SHP648. The decision to terminate study SHP648-101 is not due to any safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject SHP648 Unknown — Intravenous

Indications