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Clinical Trial Summary

This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10^13 gc/kg.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03569891
Study type Interventional
Source CSL Behring
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 27, 2018
Completion date March 2025

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