This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IV infusion, Q4W
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 years
Change from baseline in serum lactate dehydrogenase (LDH) levels.
Time frame: Up to approximately 2 years
Change from baseline in hemoglobin levels.
Time frame: Up to approximately 2 years
Proportion of patients who are transfusion-free.
Time frame: Up to approximately 2 years
Proportion of patients achieving hemoglobin levels ≥120 g/L
Time frame: Up to approximately 2 years
Proportion of patients with breakthrough hemolysis
Time frame: Up to approximately 2 years
Serum concentrations of LP-005.
Time frame: Up to approximately 2 years
Number of patients with anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
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