RecruitingPhase 4NCT05067868

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

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


Sponsor

Shire

Enrollment

5 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Replagal for people with fabry disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALReplagal

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

View Full Details on ClinicalTrials.gov

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NCT05067868


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