ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT02946463
Phase
PHASE3
Status
Completed

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria (PNH)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — BIOLOGICAL
    All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilogram (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
  • Eculizumab — BIOLOGICAL
    All treatments were given as IV infusions. Participants were administered induction doses of 600 mg followed by maintenance doses of 900 mg.

Study Details

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).

Key Dates

Start date
Dec 12, 2016
Status verified
Apr 2024
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023

Study Design

Enrollment
272 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ravulizumab
  • Active Comparator: Eculizumab

Primary Outcome Measure

Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels [ Time Frame: Day 29 through Day 183 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90033-
Research SiteWhittierCalifornia90603-
Research SiteFort WorthTexas76104-

Find similar trials in Los Angeles, CA

By research site
Research Site· Los Angeles, CAResearch Site· Whittier, CAResearch Site· Fort Worth, TX

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