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

NCT05067868 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Replagal

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

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067868 on ClinicalTrials.gov