Clinical Trial: The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction
Brief Summary: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.
Detailed Summary:
Sponsor: Prothena Therapeutics Ltd.
Current Primary Outcome: Cardiac best response as measured by NT-proBNP [ Time Frame: Baseline to 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Short Form-36 (SF-36) Questionnaire [ Time Frame: Baseline to 12 months ]
- Change in 6MWT [ Time Frame: Baseline to 12 months ]
- Renal best response as measured by proteinuria [ Time Frame: Baseline to 12 Months ]
- Change in Neuropathy Impairment Score- Lower Limb (NIS-LL) score [ Time Frame: Baseline to 12 Months ]
- Progression Free Survival [ Time Frame: Baseline to 12 Months ]
- To assess the safety of single agent NEOD001 by assessing vital signs, electrocardiogram(ECG),laboratory tests and AEs [ Time Frame: Baseline to 12 months ]
Original Secondary Outcome: Same as current
Information By: Prothena Therapeutics Ltd.
Dates:
Date Received: December 9, 2015
Date Started: March 2016
Date Completion: January 2018
Last Updated: March 30, 2017
Last Verified: March 2017
