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A Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to Eculizumab (NCT03030183)

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.
  • Drug: RA101495
    0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Diagnosis of PNH by flow cytometry
    • Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab
    Exclusion Criteria:
    • History of meningococcal disease
    • Current systemic infection or suspicion of active bacterial infection

    6 locations

    United States (6)
    • Investigative Site
      recruiting
      Duarte, California, United States, 91010
    • Investigative Site
      recruiting
      Los Angeles, California, United States, 90033
    • Investigative Site
      recruiting
      Chicago, Illinois, United States, 60612
    • Investigative Site
      recruiting
      Manhasset, New York, United States, 11030
    • Investigative Site
      recruiting
      Durham, North Carolina, United States, 27710
    • Investigative Site
      not yet recruiting
      Dallas, Texas, United States, 75390
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    16 April, 2017
    Updated:
    28 August, 2017
    Participants:
    8
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