Patient prognosis evaluation with retrospective data in severe perinatal, benign perinatal or infantile HPP: A pooled analysis from the post-marketing study and perinatal findings surveillance

Not Applicable

• Conditions: severe perinatal, benign perinatal or infantile HPP; HPP; D007014

• Registration Number: JPRN-jRCT1050220128
• Lead Sponsor: Sawai Hideaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. At the time of the PMS data lock in July 2021, Strensiq Specified drug use-results survey (post-marketing survey) Patients should have have provided data to PMS prior the data base lock date above.
2. Patients diagnosed with perinatal severe hypophosphatasia, perinatal benign hypophosphatasia, or infantile hypophosphatasia
3. A patient whose legal representative or patient can give written consent to provide patient information and a patient whose mother can give written consent to provide maternal information.

Exclusion Criteria

1. Patients diagnosed with non-perinatal and non-infantile hypophosphatasia
2. Patients in whom fetal ultrasound image data including the number of weeks of gestation before and after 28 ~ 31 weeks of gestation cannot be obtained

Study & Design

• Study Type: Observational
• Study Design: Not specified