A Phase 2/3 interventional study of MY008211A tablets in Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Wuhan Createrna Science and Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Wuhan Createrna Science and Technology Co., Ltd · Phase 2/3, 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 5th largest by planned enrollment of the 47 interventional ones, is one of 12 that started in 2024, is the only one in phase 2/3, reaches primary completion later than 13 of the 28 other live ones, and was the 34th registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's planned enrollment of 120 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 and older · 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:
This is a multicenter, single-arm, open-label study to characterize long-term safety and tolerability of MY008211A tablets and to provide access to MY008211A tablets to patients with PNH who have completed Phase 2 or 3 studies with MY008211A tablets.
The purpose of this open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of MY008211A tablets in patients with PNH and to provide access to patients who have completed (without tapering down) Phase 2 and Phase 3 trials and derived benefit from MY008211A treatment.
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.
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.
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
Participants will receive MY008211A at a dose of 400 mg orally b.i.d
Proportion of participants with adverse events, safety laboratory parameters, vital signs, ECG.
Safety evaluations including but not limited to adverse events, laboratory parameters, vital signs, ECG through End of Study visit every 12 weeks.
Time frame: About 100 weeks
Proportion of participants achieving sustained hemoglobin levels ≥ 120 g/L in the absence of red blood cell transfusions
Proportion of participants achieving sustained hemoglobin levels ≥ 120 g/L in the absence of red blood cell transfusions evaluated every 12 weeks.
Time frame: About 100 weeks
Change From Baseline in Hemoglobin
Change in hemoglobin concentration from baseline in patients without RBC transfusion every 12 weeks.
Time frame: About 100 weeks
The proportion of patients without RBC transfusion.
The proportion of patients without RBC transfusion.
Time frame: About 100 weeks
The Clinical BTH Rate
The Clinical BTH Rate
Time frame: About 100 weeks
The Major Adverse Vascular Events Rate
The Major Adverse Vascular Events Rate
Time frame: About 100 weeks
Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Lanoracopan
Wuhan Createrna Science and Technology Co., Ltd