Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LP-005 Injection.
- Who it may be relevant to
- Registry conditions: Paroxysmal Nocturnal Hemoglobinuria. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Overview
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).
Interventions
- Biological LP-005 Injection
IV infusion, Q4W
Primary outcome measures
- Incidence of adverse events (AEs) [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
- Change from baseline in serum lactate dehydrogenase (LDH) levels. [Time frame: Up to approximately 2 years]
- Change from baseline in hemoglobin levels. [Time frame: Up to approximately 2 years]
- Proportion of patients who are transfusion-free. [Time frame: Up to approximately 2 years]
- Proportion of patients achieving hemoglobin levels ≥120 g/L [Time frame: Up to approximately 2 years]
- Proportion of patients with breakthrough hemolysis [Time frame: Up to approximately 2 years]
- Serum concentrations of LP-005. [Time frame: Up to approximately 2 years]
- Number of patients with anti-drug antibodies (ADA) [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
- Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.
- Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.
- Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.
Exclusion criteria
- Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.
- Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.
- Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.
- Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT07266155 · P10-LP005-05