NCT06932744RecruitingPhase 3
Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of MY008211A Tablets in PNH Patients Who Are Naive to Complement Inhibitor Therapy
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 30 Aug 2024
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- NCT number
- NCT06932744
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 66
- From 30 Aug 2024 to the primary completion date, 30 Dec 2025
- 2 sites 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
- Previous bone marrow or hematopoietic stem cell transplantation.
- Previous splenectomy.
Other illness
- History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
- A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Lab values
- Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
Other
- Known or suspected hereditary complement deficiency.
Who the study is looking for
- Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
- Mean hemoglobin level \<100 g/L at screening.
- LDH \> 1.5 x Upper Limit of Normal (ULN) at screening.
- Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Chinese Academy of Medical Sciences Hematology Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.