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A Real-world, Multi-center, Prospective, Observational Study for PNH in China
A Real-world, Multi-center, Prospective, Observational Study for PNH in China

NCT06154512

CompletedN/A

Sponsor: AstraZeneca

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Countries: China

As a rare disease listed in the First Catalogue of Rare Diseases in China (National Health Commission of the People's Republic of China, 2019), PNH is poorly studied in China subse-quently leading to the inadequate elucidation of disease characteristics and clinical outcomes. Eculizumab was recently approved by NMPA. The availability of Eculizumab in China pro-vides people living with PNH with a new treatment option that can reduce disease symptoms and prevent the dysregulated complement system from causing further damage. A Phase Ⅳ study is necessary to understand the natural history of disease and the clinical outcomes with different medical interventions.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria

1. Patients of any age;
2. Diagnosed PNH with detected proportion of PNH clone cells of at least 1%;
3. Patient or patient's family must be willing and able to give written informed consent.

Exclusion Criteria

1. Current or previous treatment with a non-eculizumab complement inhibitor;
2. Patients in other PNH clinical trials.
3. Unable to give written informed consent.
Locations (40)
  • Hefei, Anhui, China
  • Beijing, Beijing Municipality, China
  • Beijing, Beijing Municipality, China
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Nanning, Guangxi, China
  • Guiyang, Guizhou, China
  • Shijiazhuang, Hebei, China
  • Harbin, Heilongjiang, China
  • Zhengzhou, Henan, China
  • Zhengzhou, Henan, China
  • Zhengzhou, Henan, China
  • Wuhan, Hubei, China
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Changsha, Hunan, China
  • Nanjing, Jiangsu, China
  • Nantong, Jiangsu, China
  • Xuzhou, Jiangsu, China
  • Nanchang, Jiangxi, China
  • Nanchang, Jiangxi, China
  • Changchun, Jilin, China
  • Shenyang, Liaoning, China
  • Jinan, Shandong, China
  • Qingdao, Shandong, China
  • Zibo, Shandong, China
  • Linyi, Shangdong, China
  • Shanghai, Shanghai Municipality, China
  • Shanghai, Shanghai Municipality, China
  • + 10 more on CT.gov