Clinical Trials Directory

Trials / Completed

CompletedNCT03418389

Evaluate and Monitor Physical Performance of Adults Treated With Asfotase Alfa for Hypophosphatasia

An Observational, Longitudinal Study to Evaluate and Monitor Physical Performance of Adults Treated With Asfotase Alfa for Pediatric-Onset Hypophosphatasia

Status
Completed
Phase
Study type
Observational
Enrollment
23 (actual)
Sponsor
Dr. Lothar Seefried · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Hypophosphatasia is a rare inherited metabolic disorder due to inactivating mutations of the ALPL-Gene. Particularly among adult patients, clinical manifestation exhibits a broad range of signs and symptoms, most commonly associated with musculoskeletal disabilities and compromised quality of life. Enzyme replacement therapy with Asfotase alfa (AA) is available and approved for patients with pediatric onset of the disease. This single-center observational cohort study aims at collecting clinical routine data regarding the course treatment, quality of life and physical performance in patients treated with Asfotase alfa in line with the label for pediatric-onset hypophosphatasia.

Conditions

Timeline

Start date
2018-09-05
Primary completion
2021-05-31
Completion
2021-05-31
First posted
2018-02-01
Last updated
2022-07-12

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03418389. Inclusion in this directory is not an endorsement.