Last updated on May 2020

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Paroxysmal | Myelodysplastic Syndromes (MDS) | Paroxysmal nocturnal hemoglobinuria | Hemoglobinuria | MYELODYSPLASTIC SYNDROME
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male or female aged 18 or older
  • Eculizumab-nave patients with PNH
  • Presence of the PNH white blood cell (WBC) clone 10%
  • Documented LDH level 1.5 x ULN at Screening
  • History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening
  • Subjects must be vaccinated against Neisseria meningitides

Exclusion Criteria:

  • Previous treatment with any complement pathway inhibitors
  • ANC 500/mm3 or Platelet count < 70,000/mm3
  • History of meningococcal disease
  • History of bone marrow transplantation
  • Known or suspected active bacterial/viral/fungal infection within 30 days
  • Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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