A Phase 3 interventional study of MY008211A tablets and Eculizumab Injection in Paroxysmal Nocturnal Haemoglobinuria (PNH), sponsored by Wuhan Createrna Science and Technology Co., Ltd. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Wuhan Createrna Science and Technology Co., Ltd · Phase 3, Interventional, and Treatment
Among 51 studies in Hemoglobinuria, Paroxysmal with a site in China — 21 open to participants now, 29 under way, 11 of them phase 3. Hemoglobinuria, Paroxysmal · China.
Among the 51 studies in Hemoglobinuria, Paroxysmal with a site in China, this one is the 15th largest by planned enrollment of the 47 interventional ones, is one of 12 that started in 2024, is one of 17 in phase 3, reaches primary completion later than 7 of the 28 other live ones, and was the 33rd registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's planned enrollment of 66 is above the median of 33 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →21 of the 51 studies in Hemoglobinuria, Paroxysmal with a site in China are open now, in 1 country. Each count lists the studies.
Of the 30 Hemoglobinuria, Paroxysmal studies recruiting now, 14 (47%) set no upper age limit and 12 (40%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 12 started in 2024.
Median enrollment 40 across the 47 interventional studies, 402 across the 4 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
47 of 51 have an industry lead sponsor. The 10 most frequent:
Wuhan Createrna Science and Technology Co., Ltd is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Wuhan Createrna Science and Technology Co., Ltd has 9 studies filed under Hemoglobinuria, Paroxysmal — fewer than ten, so there is no comparison to draw.
11 of the studies in Hemoglobinuria, Paroxysmal with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07177859Phase 3Nanjing Chia-tai Tianqing PharmaceuticalA Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients | 2026-11 |
| NCT06933914Phase 3Wuhan Createrna Science and Technology Co., LtdLong-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2026-12-30 |
| NCT07816237Phase 3Bisirna Therapeutics (Suzhou) Co., Ltd.A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy | 2027-09-30 |
| NCT04747613Phase 3Novartis PharmaceuticalsLong-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2027-10-18 |
| NCT07462780Shenzhen Kangzhe Biotechnology Co., Ltd.A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants | 2026-11 |
Among the 51 studies in Hemoglobinuria, Paroxysmal with a site in China, from their registry updates:
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious and safe for the treatment of PNH patients who were naive to complement inhibitor therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MY008211A tablets 400mg BID
Drug: MY008211A tablets
Eculizumab Injection
Drug: Eculizumab Injection
Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks
Eculizumab Injection for 24 weeks
The proportion of Participants With Sustained Hemoglobin Levels of ≥ 120 g/L in the Absence of Red Blood Cell Transfusions
The proportion of patients with sustained hemoglobin levels ≥ 120 g/L among those without RBC transfusion (defined as no red blood cell infusion after D14 to D168).
Time frame: between Day 126 and Day 168
The proportion of subjects with an increase in hemoglobin concentration ≥ 20 g/L from baseline among subjects who do not receive RBC transfusion
Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g/L assessed among those without RBC transfusion (defined as no red blood cell infusion after D14 to D168).
Time frame: between Day 126 and Day 168
The proportion of patients with LDH < 1.5 ULN among those without RBC transfusion.
The proportion of patients with hemolysis controlled (defined as LDH \< 1.5 ULN) among those without RBC transfusion
Time frame: between Day 126 and Day 168
Change (Expressed as Percentages) in LDH level from baseline
Change (Expressed as Percentages) in LDH level from baseline
Time frame: between Day 126 and Day 168
Change in reticulocyte count from baseline
Change in reticulocyte count from baseline
Time frame: between Day 126 and Day 168
The proportion of patients without RBC transfusion
The proportion of patients without RBC transfusion
Time frame: between Day 14 and Day 168
Change in FACIT-F score from baseline
Change from baseline in FACIT-Fatigue scores. The FACIT-Fatigue is a 13-item questionnaire with support for its validity and reliability in PNH that assesses patient self-reported fatigue and its impact on daily activities and function. All FACIT scales are scored so that a high score is better. As each of the 13 items of the FACIT-F Scale ranges from 0-4, the range of possible scores is 0-52, with 0 being the worst possible score and 52 the best.
Time frame: between Day 126 and Day 168
The Clinical BTH Rate
The Clinical BTH Rate
Time frame: between Day 1 and Day 168
The Major Adverse Vascular Events Rate
The Major Adverse Vascular Events Rate
Time frame: between Day 1 and Day 168
Started Aug 2024 (actual). Primary completion is estimated for Dec 2025, 16 months after the start.
Of 35 industry-sponsored phase 3 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's planned 16 months is below that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 15 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Lanoracopan
Wuhan Createrna Science and Technology Co., Ltd