Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT06079372

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Phase 3 – large-scale trial before approval
Conditions: Hypophosphatasia

Sponsor: Alexion Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.
Who can participate
Inclusion Criteria: * Diagnosis of HPP documented in the medical records * Presence of open growth plates by X-ray during Screening Period * Tanner stage 2 or less during the Screening Period * Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator. * Diagnosis of primary or secondary hyperparathyroidism * Hypoparathyroidism, unless secondary to HPP * Any new fracture within 12 weeks before Day 1 (excluding pseudofractures) * Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period * History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850 * Body weight \< 10 kg during the Screening Period
Locations 7
Argentina (1)
Research Site
Mar del Plata
Australia (1)
Research Site
South Brisbane
Canada (1)
Research Site
Ottawa , Ontario
Japan (1)
Research Site
Bunkyō City
Turkey (1)
Research Site
Altındağ
United Kingdom (1)
Research Site
Birmingham
United States (1)
Research Site
Hartford , Connecticut
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
11 Years
Healthy volunteers
No
Start date
02.04.2024
Completion date
29.02.2028
Registry ID
NCT06079372
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.