WHO ICTRP trial
A Replagal study in Indian Children and Adults With Fabry Disease
CTRI/2021/12/038690 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/12/038690 |
|---|---|
| Public title | A Replagal study in Indian Children and Adults With Fabry Disease |
| Scientific title | A Prospective, Open-label, Multicentre, Interventional, Single-arm, Phase IV Study to Evaluate the Safety and Efficacy of Agalsidase alfa (r-DNA origin) (Replagalâ?¢) in Indian Children and Adults With Fabry Disease - NA |
| Primary sponsor | Shire Biotech India Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 4 |
| Countries | India |
| Conditions | Health Condition 1: E752- Other sphingolipidosis |
| Interventions | Intervention1: Replagal: Each single-use vial of Replagal contains 3.5 mg of agalsidase alfa in 3.5 mL of solution. Control Intervention1: Nil: Nil |
| Registration date | Dec 16, 2021 |
| Target size | 5 |
| Secondary IDs | TAK-675-4008 version 2.0 dated 22 February 2021 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: