NCT07212426Active, not recruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients.
A Phase II, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria.
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 30 Sept 2025
- Start date
- 14 Nov 2024
- Primary completion date
- 6 May 2026
- Lead sponsor
- Longbio Pharma
- NCT number
- NCT07212426
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 14 Nov 2024 to the primary completion date, 6 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening.
- Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer).
Other illness
- 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.
Other
- Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.