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NCT07177859
A Multicenter, Randomized, Open-label, Active-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
Phase 3 trial testing NTQ5082 capsules 200 mg in Paroxysmal Nocturnal Hemoglobinuria in 78 participants. Not yet recruiting.
1 November 2026
Quick facts
| Lead sponsor | Nanjing Chia-tai Tianqing Pharmaceutical |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 November 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- NTQ5082 capsules 200 mg — full drug profile →
- Eculizumab Injection — full drug profile →
Conditions studied
- Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →
Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical — full company profile →
Who can join
18 and older, any sex, with Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of subjects with hemoglobin (HB) levels ≥120 g/L on at least three of the four measurements between Weeks 18 and 24 in the absence of red blood cell (RBC) transfusions (defined as no RBC transfusions after Week 2 (D15) until Week 24 (D169))
Time frame: Weeks 18 to 24
Sponsor's own description
NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, randomized, open-label, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07177859
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria
Currently open trials in the same condition.
- NCT07457151 — Danicopan PMS in Korea · recruiting
- NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
- NCT07470762 — Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 1, PHASE2 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07413679 — Long-term Safety of Danicopan: IPIG Registry-based Cohort Study · active not recruiting
Other Nanjing Chia-tai Tianqing Pharmaceutical trials
Trials by the same sponsor.
- NCT07462130 — An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED) · Phase 1, PHASE2 · not yet recruiting
- NCT07393321 — A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HE · Phase 3 · not yet recruiting
- NCT06977763 — Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection · NA · not yet recruiting
- NCT07182552 — Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics of NTB003 in Healthy Participants · Phase 1 · enrolling by invitation
- NCT06977750 — Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07177859 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanjing Chia-tai Tianqing Pharmaceutical
- Last refreshed: 10 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07177859.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing