Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease

Study Identifier:
CLI-06657AA2-01
ClinicalTrials.gov Identifier:
NCT05710692
EudraCT Identifier:
N/A
Study Contact Information:
+3905212791 or [email protected]
Recruiting

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: PRX-102 1 mg/kg every 2 weeks
  • Drug: PRX-102 2 mg/kg every 4 weeks
Date
Aug 2023 - Mar 2026
Patient Requirements
Sex: Female & Male
Age: 13 - 60 Years
Requirements Information
Healthy Volunteers
No

Protocol Summary

The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned of a total of approximately 18-20 male and female Fabry disease patients between the ages of 13 and 60 years to be part of the study. The study is conducted in Japan.

Study Locations

Location
Status
Location
Fukuoka University Chikushi Hospital
Chikushino, Fukuoka, Japan, 818-8502
Status
Recruiting
Location
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Status
Recruiting
Location
University of the Ryukyu Hospital
Nishihara, Okinawa, Japan, 903-0125
Status
Recruiting
Location
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Status
Recruiting
Location
Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo
Bunkyo-ku, Tokyo, Japan, 113-0033
Status
Recruiting
Location
Tokyo Jikei University Hospital
Minato-ku, Tokyo, Japan, 105-8461
Status
Recruiting