Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Hereditary Thrombotic Thrombocytopenic Purpura (TTP) Clinical Trial

Official title: BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Status Completed

Clinical Trial Summary

The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%) who are assigned to one of three dose cohorts.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic

• NCT number: NCT02216084
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2014
• Completion date: February 22, 2016