Clinical Trial: Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed 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. 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.
Sponsor: Prothena Therapeutics Ltd.

Current Primary Outcome: Long-term safety and tolerability of NEOD001 in study participants through vital signs, ECGs, routine laboratory assessments and frequency/severity of adverse events. [ Time Frame: Study duration is 12 months ]

Long-term safety and tolerability of NEOD001 in study participants through vital signs, ECGs, routine laboratory assessments and frequency/severity of adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Prothena Therapeutics Ltd.

Dates:
Date Received: November 18, 2015
Date Started: February 2016
Date Completion: December 2017
Last Updated: September 7, 2016
Last Verified: September 2016