deltatrials
Recruiting PHASE4 INTERVENTIONAL 1-arm NCT05067868

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

Conditions Fabry Disease
Interventions Replagal
Updated 12 times since 2021 Last updated: Sep 15, 2025 Started: Nov 1, 2022 Primary completion: Oct 31, 2026 Completion: Nov 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Fabry Disease, this trial is actively recruiting participants. The trial is conducted by Shire and has accumulated 12 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshotNot Yet Recruiting~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshotNot Yet Recruiting~Mar 2022 – ~Jun 2022 · 3 months · monthly snapshotNot Yet Recruiting~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshotNot Yet Recruiting~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshotNot Yet Recruiting~Dec 2022 – ~Apr 2023 · 4 months · monthly snapshotRecruiting~Apr 2023 – ~Jun 2024 · 14 months · monthly snapshotActive Not Recruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotActive Not Recruiting~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshotActive Not Recruiting~Oct 2025 – present · 9 months · monthly snapshotRecruiting

Change History

12 versions recorded
  1. Oct 2025 — Present [monthly]

    Recruiting PHASE4

    Status: Active Not RecruitingRecruiting

  2. Aug 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE4

  3. Sep 2024 — Aug 2025 [monthly]

    Active Not Recruiting PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE4

  5. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE4

Show 7 earlier versions
  1. Apr 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

  2. Dec 2022 — Apr 2023 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  3. Sep 2022 — Dec 2022 [monthly]

    Not Yet Recruiting PHASE4

  4. Jun 2022 — Sep 2022 [monthly]

    Not Yet Recruiting PHASE4

  5. Mar 2022 — Jun 2022 [monthly]

    Not Yet Recruiting PHASE4

  6. Jan 2022 — Mar 2022 [monthly]

    Not Yet Recruiting PHASE4

  7. Nov 2021 — Jan 2022 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
  • Takeda
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations