A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, randomized, open-label, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria.

Eligibility criteria

Qualifiers

None

Disqualifiers

1) During the screening period, laboratory (local laboratory) results show bone marrow failure (reticulocyte count <100×109/L, or platelet count <30×109/L [must not have received platelet transfusion within 7 days prior to the laboratory test], or neutrophil count <0.5×109/L [must not have received short-acting granulocyte colony-stimulating factor within 14 days or long-acting granulocyte colony-stimulating factor within 28 days prior to the laboratory test]).

Trial design

Treatments tested in this trial

  • NTQ5082 capsules 200 mg
  • Eculizumab Injection

Treatment groups

78 Participants
are divided into 2 treatment groups