A Phase 2 interventional study of HSK39297 tablets in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 2, 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 21st largest by planned enrollment of the 47 interventional ones, is one of 12 that started in 2025, is one of 13 in phase 2, reaches primary completion later than 18 of the 28 other live ones, and was the 27th registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's planned enrollment of 47 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 2025.
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:
Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 118 studies on the registry; 51 are open to participants now.
Haisco Pharmaceutical Group Co., Ltd. has 5 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, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.
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:
Drug: HSK39297 tablets
HSK39297 tablets until the end of treatment
Incidence and severity of adverse events
Time frame: through study completion，about 2 years
Proportion of participants achieving hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions
Time frame: through study completion，about 2 years
Change From Baseline in Hemoglobin in the absence of red blood cell transfusions
Time frame: through study completion，about 2 years
Proportion of participants who remain free from transfusions
Time frame: through study completion，about 2 years
Rate of breakthrough hemolysis (BTH)
Time frame: through study completion，about 2 years
Proportion of participants with Major Adverse Vascular Events (MAVEs)
Time frame: through study completion，about 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jun 2027, 29 months later.
Of 26 industry-sponsored phase 2 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's planned 29 months is above that.
Counting every sponsor, half of 34 studies reached it within 24 months; a quarter within 12 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: HSK39297
Haisco Pharmaceutical Group Co., Ltd. →