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Clinical Trials in China / NCT07177872
Starting soon Phase 3

A Long-term Efficacy and Safety of NTQ5082 Capsules

NCT07177872 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical
Phase
Phase 3
Started
2026-06
Last updated
2025-09-17

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

NTQ5082 capsules 200 mg

NTQ5082 capsules 200 mg: NTQ5082 capsules 200 mg

Study summary

NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, open-label study evaluating the long-term efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 1\) Age ≥ 18 years, regardless of gender. 2) Subjects who have previously received and completed NTQ5082 study treatment and, as determined by the investigator, have benefited from treatment and are likely to benefit from continued NTQ5082 treatment, or subjects in the control group receiving eculizumab. 3\) Subjects who have received ACYW135 group meningococcal and pneumococcal vaccines as required by the previous protocol, and whose vaccine protection period, as determined by the investigator, falls within the treatment duration of this study. 4\) Subjects who agree to use at least one effective contraceptive method during sexual intercourse with their partner from the time they sign the informed consent form until 4 weeks after the last dose, refrain from cryopreservation of sperm or eggs, and refrain from sperm or egg donation. 5\) Subjects who agree to sign the informed consent form and commit to abide by all study regulations. Exclusion Criteria: * 1\) Previous history of bone marrow/hematopoietic stem cell or solid organ transplant (e.g., heart, lung, kidney, liver). 2\) Previous history of splenectomy. 3) Previous history of recurrent invasive infection with encapsulated bacteria (e.g., meningococci, Streptococcus pneumoniae), previous history of systemic anti-tuberculosis treatment, or current tuberculosis infection. 4\) History of malignancy within 5 years prior to screening, excluding cured localized basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or carcinoma in situ of the cervix. 5\) Known or suspected hereditary complement deficiency or primary or severe secondary immunodeficiency. 6) Patients with a history of clinically significant kidney, heart, liver, or lung disease who are deemed unsuitable for participation by the investigator, including but not limited to severe kidney disease (e.g., eGFR \<30 mL/min/1.73 m²), advanced heart disease (e.g., NYHA class IV), or severe lung disease (e.g., severe pulmonary hypertension (WHO class IV). 7\) Patients suspected of being allergic to the study drug or any component of the study drug. 8\) Pregnant or lactating female subjects. 9) Other conditions deemed unsuitable for participation by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences , Tianjin Tianjin Municipality

More Nanjing Chia-tai Tianqing Pharmaceutical trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177872 on ClinicalTrials.gov ↗ ← All trials in China