Paroxysmal Nocturnal Hemoglobinuria
Conditions
Brief summary
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
BIOLOGICALLP-005 Injection
IV infusion, Q4W
Sponsors
Longbio Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF). 2. 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. 3. 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. 4. 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
1. Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug. 2. Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment. 3. Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment. 4. Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in serum lactate dehydrogenase (LDH) levels. | Up to approximately 2 years |
| Change from baseline in hemoglobin levels. | Up to approximately 2 years |
| Proportion of patients who are transfusion-free. | Up to approximately 2 years |
| Proportion of patients achieving hemoglobin levels ≥120 g/L | Up to approximately 2 years |
| Proportion of patients with breakthrough hemolysis | Up to approximately 2 years |
| Serum concentrations of LP-005. | Up to approximately 2 years |
| Number of patients with anti-drug antibodies (ADA) | Up to approximately 2 years |
Countries
China
Contacts
Primary ContactTingyuan Yang
Outcome results
None listed