WHO ICTRP trial
Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of…
CTRI/2024/08/072953 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2024/08/072953 |
|---|---|
| Public title | Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Eliglustat Sublingual Film in Patients with Gaucher Disease Type 1. |
| Scientific title | A Multicenter, Open-Label, Single-Arm, Two-Cohort, Phase 3, Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Eliglustat Sublingual Film in Patients with Gaucher Disease Type 1. - NIL |
| Primary sponsor | Kashiv Biosciences Pvt. Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: E752- Other sphingolipidosis |
| Interventions | Intervention1: Eliglustat sublingual film: Adult patients will be given 16 mg twice daily (sublingually) for 28 Days and after that it will be increased to 24 mg twice daily till end of study (Week 39), based on CTrough Levels of Eliglustat… |
| Registration date | Aug 23, 2024 |
| Target size | 12 |
| Secondary IDs | CE-24-03 (Version 01 Dated: 19 April 2024) |
| Registry page | ctri.nic.in |
At a glance
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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: