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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.