Trial · NCT07905287
Clarify HPP: Disease Burden of HPP Patients in China
NCT07905287, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clarify HPP: Disease Burden of HPP Patients in China. Trials, record NCT07905287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clarify HPP: Disease Burden of HPP Patients in China
- NCT number
- NCT07905287
- Status
- Recruiting
- Enrollment
- 200 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Hypophosphatasia (HPP)
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). | Baseline, Month 3, Month 6, Month 9, and Month 12 | 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. |
| Primary | 5-18 years pediatric participants: SF-10 absolute values at baseline, 3, 6, 9, 12 months (including PCS, MCS) | Baseline, Month 3, Month 6, Month 9, and Month 12 | 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. |
| Primary | 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) | Baseline, Month 3, Month 6, Month 9, and Month 12 | 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. |
| Primary | 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). | Baseline, Month 3, Month 6, Month 9, and Month 12 | To evaluate the quality of life in Chinese pediatric patients aged 13-24 months with HPP using PedsQL Infant Scales (ages 13-24 months). |
| Primary | 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) | Baseline, Month 3, Month 6, Month 9, and Month 12 | 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. |
| Secondary | 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 | To assess the severity of pain in Chinese adult HPP patients using BPI-SF. BPI-SF includes 4 items that assess pain severity (11-point scale: 0 = no pain, 10 = worst pain you can imagine) and 7 items that assess pain interference with functioning (11- point scale: 0 = does not interfere, 10 = completely interferes) in the preceding 24 hours. A total pain severity score (BPI-SF-PS; range: 0-40) is calculated from the 4 items of pain intensity, with each item weighted equally in the final score. A total pain interference score (BPI-SF-PI; range: 0-70) is calculated from the 7 items on pain interference, each contributing the same weight to the final score. |
| Secondary | 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 | To assess the severity of pain in Chinese pediatric HPP patients using PODCI Pain/Comfort subscale. The PODCI includes functional subscales, in this study, only the Pain/Comfort subscale will be used. Standardized scores for the Pain/Comfort subscale range from 0 to 100, with higher scores indicating less pain and better comfort/health status. |
| Secondary | Adult participants: FACIT-Fatigue absolute values at baseline, 3, 6, 9, 12 months | Baseline, Month 3, Month 6, Month 9, and Month 12 | To evaluate the level of fatigue in Chinese adult HPP patients using FACIT-Fatigue. The FACIT-Fatigue comprises 13 items, each rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Higher scores indicate less severe fatigue and better functional status. |
| Secondary | 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 | To evaluate the level of fatigue in Chinese pediatric HPP patients using Peds FACIT-Fatigue. Scores will be calculated in accordance with the applicable Peds FACIT-Fatigue scoring manual, with higher scores indicating less fatigue and better functioning. |
| Secondary | 30 seconds STS absolute values at baseline, 6 and 12 months | Baseline, Month 6, and Month 12 | To assess the functional status of Chinese HPP patients using 30 seconds STS. The test result is recorded as the number of complete sit-to-stand repetitions completed within 30 seconds, more repetitions indicate better lower limb muscle strength, endurance, and functional mobility. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07905287
GET https://conductscience.org/api/trials/v1/NCT07905287/registered