Status:
RECRUITING
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients.
Lead Sponsor:
Longbio Pharma
Conditions:
PNH - Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 hemoglobin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07212426
Start Date
November 14 2024
End Date
March 31 2028
Last Update
October 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China