Clinical Trial: ALXN1210 Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuri

Brief Summary: The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with PNH who have not previously used a complement inhibitor.

Detailed Summary:
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome:

  • Normalization of lactate dehydrogenase (LDH) levels [ Time Frame: 26 weeks ]
    Achievement of LDH values within the laboratory normal range will be compared between treatment groups. LDH is an indicator of intravascular hemolysis that occurs in patients with paroxysmal nocturnal hemoglobinuria (PNH). A decrease in LDH from above the upper limit of normal (ULN) to below the ULN indicates reduction (improvement) in hemolysis.
  • Percentage of patients who achieve transfusion avoidance (TA) [ Time Frame: 26 weeks ]


Original Primary Outcome:

  • Normalization of lactate dehydrogenase (LDH) levels [ Time Frame: 26 weeks ]
  • Percentage of patients who achieve transfusion avoidance (TA) [ Time Frame: 26 weeks ]


Current Secondary Outcome:

  • Percentage change from baseline in lactate dehydrogenase ( LDH) levels [ Time Frame: 26 weeks ]
  • 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 with stabilized hemoglobin [ Time Frame: 26 weeks ]


Original Secondary Outcome: Same as current

Information By: Alexion Pharmaceuticals

Dates:
Date Received: October 25, 2016
Date Started: September 2016
Date Completion: December 2019
Last Updated: April 26, 2017
Last Verified: April 2017