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RECRUITING
NCT05067868
PHASE4

A Study of Replagal in Children and Adults With Fabry Disease in India

Sponsor: Shire

View on ClinicalTrials.gov

Summary

The main aim of this study is to learn more about the safety profile of Replagal. Participants will receive Replagal every 2 weeks at the clinic for about 1 year.

Official title: A Prospective, Open-label, Multicentre, Interventional, Single-arm, Phase IV Study to Evaluate the Safety and Efficacy of Replagal (Agalsidase Alfa [r-DNA Origin]) in Indian Children and Adults With Fabry Disease

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2022-11-01

Completion Date

2026-11-30

Last Updated

2025-09-19

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Replagal

Participants will receive Replagal 0.2 mg/kg, intravenous infusion at Day 1 and every 2 weeks.

Locations (3)

Institute of Child Health

Kolkata, India

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

Sir Gangaram Hospital

New Delhi, India