NCT07177872尚未招募3 期
A Multicenter, Open-label Study Evaluating the Long-term Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
Nanjing Chia-tai Tianqing Pharmaceutical1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年6月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NTQ5082
Experimental
NTQ5082
干预措施: NTQ5082 capsules 200 mg (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 96 Weeks
次要结局
- the proportion of subjects with hemoglobin (HB) levels ≥ 120 g/L without red blood cell (RBC) transfusion(96 weeks)
- the change in hemoglobin level compared to before NTQ5082 capsule treatment without red blood cell transfusion(96 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria PatientsNCT07177859Nanjing Chia-tai Tianqing Pharmaceutical78
尚未招募
1 期
Effect of Food of NTQ5082 in Healthy SubjectsComplement-mediated Hemolytic DiseasesNCT06558656Nanjing Chia-tai Tianqing Pharmaceutical12
进行中（未招募）
2 期
A Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria PatientsParoxysmal Nocturnal HemoglobinuriaNCT06764303Nanjing Chia-tai Tianqing Pharmaceutical24
尚未招募
1 期
A Phase 1 Clinical Trial of NTQ5082 in Healthy VolunteersComplement-mediated Hemolytic DiseasesNCT06560593Nanjing Chia-tai Tianqing Pharmaceutical82
尚未招募
2 期
Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA NephropathyNCT06982040Nanjing Chia-tai Tianqing Pharmaceutical80