WHO ICTRP trial
A Phase III Multicenter, Randomized, Double-Blind Trial to Assess the Safety and…
EUCTR2007-000498-42-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2007-000498-42-GB |
|---|---|
| Public title | A Phase III Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients with Gaucher Disease - NA |
| Scientific title | A Phase III Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients with Gaucher Disease - NA |
| Primary sponsor | Protalix Biotherapeutics |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Spain;Italy;United Kingdom |
| Conditions | Gaucher disease MedDRA version: 9.1 Level: PT Classification code 10018048 Term: Gaucher's disease |
| Interventions | Product Name: recombinant human glucocerebrosidase Product Code: prGCD Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: prGCD Other descriptive name: recombinant human glucocerebrosidase Concentration unit: U… |
| Registration date | Jul 1, 2008 |
| Target size | 30 |
| Secondary IDs | PB-06-001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: