Trials / Recruiting
RecruitingNCT05067868
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replagal | Participants will receive Replagal 0.2 mg/kg, intravenous infusion at Day 1 and every 2 weeks. |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2026-10-31
- Completion
- 2026-11-30
- First posted
- 2021-10-05
- Last updated
- 2025-09-19
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05067868. Inclusion in this directory is not an endorsement.