CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
REPLAGALbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04974749
NCT04974749Phase 3Completed
CompareCT.gov

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of REPLAGAL® in Treatment-naïve Chinese Subjects With Fabry Disease

Takeda·interventional·Posted Jul 23, 2021·Updated Oct 8, 2024

In Brief

A Phase 3 clinical trial evaluating REPLAGAL for Fabry Disease. Completed, enrolled 20 participants across 6 sites.

Detailed Summary

The main aim of the study is to assess the safety of REPLAGAL. Study participants will receive REPLAGAL as an intravenous infusion every other week for 52 weeks. Participants will visit their study clinic many times throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 23, 2021
Enrollment StartMay 1, 2022
Primary CompletionJan 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago

Interventions

REPLAGALbiological

REPLAGAL IV infusion.