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prGCD (Taliglucerase alfa) in Gaucher Disease
NCT00376168Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2007
- Primary completion
- Sep 2009
- Countries
- 8
- Sponsor
- Pfizer
- Modality
- Replacement Enzymes
- Drugs
- taliglucerase alfa
- Conditions
- Gaucher disease (GD)
01
Overview
Phase 3, randomised, double-blind trial of taliglucerase alfa in Gaucher disease (GD) (2 arms), sponsored by Pfizer. Primary endpoint: Change From Baseline in Spleen Volume Measured by MRI at 9 months. Started Aug 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
prGCD 30 U/kg
30 units/kg every 2 weeks
prGCD 60 U/kg
60 units/kg every 2 weeks
03
Who it enrols
Adult patients with confirmed Gaucher disease, splenomegaly (>8x normal), and thrombocytopenia/anemia, who are treatment-naïve or have not received ERT/SRT in the past 12 months.
04
Endpoints
Primary
Change From Baseline in Spleen Volume Measured by MRI
Secondary
Change From Baseline in Liver Volume
Change in Hemoglobin
Change in Platelet Count
05
Results
Primary endpoints met
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