Clinical Trial: ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated

Brief Summary: The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with PNH who are clinically stable on eculizumab for at least 6 months

Detailed Summary:
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome: Hemolysis as directly measured by percentage change in LDH levels [ Time Frame: 26 weeks ]

The difference between treatment arms in LDH-PCHG from Baseline to Day 183


Original Primary Outcome: Hemolysis as directly measured by percentage change in LDH levels [ Time Frame: 26 weeks ]

Current Secondary Outcome:

  • Change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: 26 weeks ]
    Change in quality of life as assessed by the FACIT-Fatigue scale will be compared between the treatment groups from Baseline to Day 183
  • Percentage of patients who achieve Transfusion Avoidance (TA) [ Time Frame: 26 weeks ]
    The proportion of patients who remain transfusion-free will be compared between treatment groups from Baseline to Day 183
  • Percentage of patients with stabilized hemoglobin [ Time Frame: 26 weeks ]
    The percentage of patients with stabilized hemoglobin will be compared between the treatment groups from Baseline to Day 183.


Original Secondary Outcome:

  • Change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: 26 weeks ]
  • Percentage of patients who achieve Transfusion Avoidance (TA) [ Time Frame: 26 weeks ]
  • Percentage of patients with stabilized hemoglobin [ Time Frame: 26 weeks ]


Information By: Alexion Pharmaceuticals

Dates:
Date Received: February 14, 2017
Date Started: April 2017
Date Completion: March 2020
Last Updated: April 19, 2017
Last Verified: April 2017