Cardiac Arrhythmia Suppression Trial

Prothena Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA

Retrieved on: 
Monday, February 1, 2021
Clinical trials, Medical statistics, Clinical endpoint, Clinical research, Health, Mortality, Major adverse cardiovascular events, Public health, Cardiac Arrhythmia Suppression Trial

This registration-enabling study will be conducted with a primary endpoint of all-cause mortality at p

Key Points: 
  • This registration-enabling study will be conducted with a primary endpoint of all-cause mortality at p
  • Global, multi-center, double-blind, placebo-controlled, 2:1 randomized, time-to-event study expected to enroll approximately 150 newly diagnosed, treatment nave patients with AL amyloidosis categorized as Mayo Stage IV.
  • Significant changes observed on secondary endpoints provided further evidence of clinical benefit in birtamimab-treated Mayo Stage IV patients in VITAL.
  • For more information on AL amyloidosis, please visit the websites of the Amyloidosis Support Groups , The Amyloidosis Research Consortium , and the Amyloidosis Foundation .

DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Retrieved on: 
Wednesday, September 16, 2020
Clinical trials, Health, Clinical research, Design of experiments, Placebo-controlled study, Medical research, Drugs, Breakthrough therapy, Monoclonal antibodies, Cardiac Arrhythmia Suppression Trial, Tcelna, AdrenOSS-2 study design & analysis, Adrecizumab and Adrenomedullin, Adrenomed

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.

Arch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation

Retrieved on: 
Thursday, April 23, 2020
Medical specialties, Medicine, Intensive care medicine, Acute respiratory distress syndrome, Respiratory physiology, Cardiac Arrhythmia Suppression Trial, Teprotumumab

The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide.

Key Points: 
  • The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide.
  • A secondary endpoint of the Phase II study is to prevent kidney inflammation and injury, which also contributes to the mortality of COVID19 patients.
  • Patients with severe COVID19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care.
  • A total of 52 healthy, normal volunteers received dosing of Metablok during the Phase I human trial.

Bellerophon Completes Enrollment in Cohort 2 of Ongoing Phase 2/3 Study of INOpulse® for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Retrieved on: 
Thursday, August 1, 2019
Clinical research, Deception, Placebo, Design of experiments, Articles, Research, Cardiac Arrhythmia Suppression Trial

We have been extremely pleased with the rate of enrollment in Cohort 2, and are thankful for the continued support and enthusiasm from our sites.

Key Points: 
  • We have been extremely pleased with the rate of enrollment in Cohort 2, and are thankful for the continued support and enthusiasm from our sites.
  • We look forward to study completion by year-end 2019, said Fabian Tenenbaum, Chief Executive Officer of Bellerophon.
  • Subjects will complete 16 weeks of blinded treatment on iNO45 vs placebo, and then continue onto open-label treatment.
  • The study is expected to include approximately 300 subjects randomized 1:1 to active or placebo for 16 weeks of blinded treatment.