NCT07905287|Recruiting
Clarify HPP: Disease Burden of HPP Patients in China
A Multi-Center, Prospective, Observational Study of the Disease Burden of Hypophosphatasia (HPP) Patients in China
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A Multi-Center, Prospective, Observational Study of the Disease Burden of Hypophosphatasia (HPP) Patients in China
Sponsor study identifier
observational
200
1 country
22
Study Start
September 26, 2026
Actual (reported)Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A multi-Center, prospective, observational study of the disease burden of Hypophosphatasia (HPP) patients in China. The study aims to prospectively collect real-world outcome data on HPP, including QoL, clinical manifestations, patient-reported outcomes (PROs) among Chinese HPP patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2026
Actual (reported)September 26, 2026
Actual (reported)October 29, 2026
Actual (reported)October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Adults: SF-36 V2.0 absolute values at baseline and months 3, 6, 9 and 12, including Physical and Mental Component Summary scores and 8 domains (physical functioning/role, pain, general health, vitality, social functioning/role, mental health).
To evaluate the quality of life in Chinese adult patients with HPP using SF-36 V2.0. Raw scores of the 8 domains and the two summary scores are converted to a standardized 0-100 scale, with higher scores indicating better overall physical and mental quality of life.
Baseline, Month 3, Month 6, Month 9, and Month 12
5-18 years pediatric participants: SF-10 absolute values at baseline, 3, 6, 9, 12 months (including PCS, MCS)
To evaluate the quality of life in Chinese pediatric patients aged 5-18 years with HPP using SF-10. It assesses core physical and mental health dimensions, with results summarized into a continuous total score (0-100 scale) reflecting overall physical and mental health, higher total scores correspond to better pediatric health-related quality of life.
Baseline, Month 3, Month 6, Month 9, and Month 12
2-4 years pediatric participants: PedsQL 4.0 Toddler Version absolute values at baseline, 3, 6, 9, 12 months (total score and 4 domain summary scores including physical functioning, emotional functioning, social functioning, school functioning)
To evaluate the quality of life in Chinese pediatric patients aged 2-4 years with HPP using PedsQL 4.0 Toddler Version. All items are completed on a 5-point Likert scale, and scores are transformed to a 0-100 scale where higher scores represent better health-related quality of life.
Baseline, Month 3, Month 6, Month 9, and Month 12
Pediatric participants aged 13-24 months: PedsQL Infant Scales absolute values at baseline and months 3, 6, 9 and 12, including total score and 5 domains (physical functioning/symptoms, emotional, social and cognitive functioning).
To evaluate the quality of life in Chinese pediatric patients aged 13-24 months with HPP using PedsQL Infant Scales (ages 13-24 months).
Baseline, Month 3, Month 6, Month 9, and Month 12
1-12 months pediatric participants: PedsQL Infant Scales ages 1-12 months (total score and 5 domain summary scores including physical functioning, physical symptoms, emotional functioning, social functioning, cognitive functioning)
To evaluate the quality of life in Chinese pediatric patients aged 1-12 months with HPP using PedsQL Infant Scales (ages 1-12 months). All items are completed on a 5-point Likert scale, and scores are transformed to a 0-100 scale where higher scores represent better health-related quality of life.
Baseline, Month 3, Month 6, Month 9, and Month 12
Adult participants: BPI-SF absolute values at baseline, 3, 6, 9, 12 months (total pain severity score and total pain interference score)
Baseline, Month 3, Month 6, Month 9, and Month 12
Pediatric participants: PODCI Pain/Comfort subscale absolute values at baseline, 3, 6, 9, 12 months (PODCI Pain/Comfort score)
Baseline, Month 3, Month 6, Month 9, and Month 12
Adult participants: FACIT-Fatigue absolute values at baseline, 3, 6, 9, 12 months
Baseline, Month 3, Month 6, Month 9, and Month 12
Pediatric participants (8-18 years): Peds FACIT-Fatigue absolute values at baseline, 3, 6, 9, 12 months
Baseline, Month 3, Month 6, Month 9, and Month 12
30 seconds STS absolute values at baseline, 6 and 12 months
Baseline, Month 6, and Month 12
Participants with confirmed HPP diagnosis meeting inclusion criteria (at least one HPP-consistent clinical manifestation, persistently low ALP, positive ALPL gene test or elevated PLP) and no exclusion criteria (prior asfotase alfa use, recent interventional trial participation, severe comorbidities, poor compliance to study procedure).
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Weibo Xia, MD
Peking Union Medical College Hospital
AstraZeneca Clinical Study Information Center
CONTACT
First Submitted
September 7, 2026
First Posted
October 29, 2026
Study Start
September 26, 2026
Actual (reported)Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)
Contact the study team to confirm eligibility.
Research Site
Chongqing, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Huai'an, China
Research Site
Jinan, China
Research Site
Nanchang, China
Research Site
Qingdao, China
Research Site
Shanghai, 200233, China
Research Site
Shanghai, 201102, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Shenzhen, China
Research Site
Suzhou, China
Research Site
Tianjin, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Research Site
Zhengzhou, China
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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