Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT07266155 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-12-05
Summary
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).
Conditions
Interventions
- BIOLOGICAL
-
LP-005 Injection
IV infusion, Q4W
Sponsors & Collaborators
-
Longbio Pharma
lead INDUSTRY
Principal Investigators
-
Guangsheng He · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-05
- Primary Completion
- 2027-12-30
- Completion
- 2028-05-01
Countries
- China
Study Locations
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