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 ]
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