Clinical Trials in China / NCT07212426
Active, not recruiting
Phase 2
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients.
NCT07212426 · tracked via the Priya Life Science China tracker
Condition(s) studied
PNH - Paroxysmal Nocturnal Hemoglobinuria
Study summary
This is a multicenter, randomized, open-label, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Eligibility
Inclusion Criteria:
* Male or female, aged 18 to 65 years.
* Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes.
* Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH.
* LDH level ≥2.0×upper limit of the normal range(ULN).
* Hemoglobin level \<100 g/L at screening.
Exclusion Criteria:
* Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening.
* History of meningococcal infection.
* History of splenectomy or congenital asplenia.
* History of systemic autoimmune disease or known/suspected immunodeficiency.
* History of hematopoietic stem cell transplantation.
* Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer).
* Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.
Primary outcome measure(s)
- Change from Baseline in serum lactate dehydrogenase (LDH) levels. — Baseline and at Week 12.
- Proportion of participants with ≥2 g/dL increase in hemoglobin level from Baseline in the absence of transfusion. — Baseline and at Week 24.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | China |
More Longbio Pharma trials in China
A Study of Single Dose of LP-003 in Healthy Adult Subjects
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07212426 on ClinicalTrials.gov ↗ ← All trials in China