A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

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• Hemoglobinuria, Paroxysmal 188

Hemoglobinuria, Paroxysmal

188 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 48 are open to participants now.

This study's enrollment of 76 is above the median of 34 across 147 interventional studies indexed under Hemoglobinuria, Paroxysmal.

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd. is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Study arms

• Experimental
  HRS-5965 capsule

  Drug: HRS-5965 capsule

• Experimental
  Eculizumab Injection

  Drug: Eculizumab Injection

Interventions

• DrugHRS-5965 capsule

  HRS-5965 capsule for 24 weeks

• DrugEculizumab Injection

  Eculizumab Injection for 24 weeks

Primary outcomes

1. Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions

   Time frame: 24 weeks

Secondary outcomes

1. Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions

   Time frame: 24 weeks

2. Proportion of subjects who absence of administration of red blood cell transfusions

   Time frame: 24 weeks

3. Mean change from baseline in hemoglobin

   Time frame: 24 weeks

4. Mean percent change from baseline in LDH levels

   Time frame: 24 weeks

5. Mean change from baseline in reticulocyte counts

   Time frame: 24 weeks

6. Mean change from baseline in FACIT-Fatigue scores

   Time frame: 24 weeks

Individual participant data

Plan to share: Undecided