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Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis — OLE  

AL Amyloidosis Clinical Trial

Official title:
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Clinical Trial Summary

The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.

Clinical Trial Description

The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study. The primary objective of the study is to evaluate long-term safety and tolerability of NEOD001 and the secondary objectives are to assess the immunogenicity of NEOD001 and to incorporate serum NEOD001 concentrations in a population pharmacokinetic (PK) analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02613182
Study type Interventional
Source Prothena Therapeutics Ltd.
Contact
Status Terminated
Phase Phase 2
Start date February 2016
Completion date May 2018
View Details
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