Trials / Completed
CompletedNCT01411228
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Taliglucerase alfa | Taliglucerase alfa for infusion every two weeks for 24 months |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2014-07-01
- Completion
- 2014-08-01
- First posted
- 2011-08-08
- Last updated
- 2018-09-07
- Results posted
- 2016-01-18
Locations
3 sites across 3 countries: Israel, Paraguay, South Africa
Source: ClinicalTrials.gov record NCT01411228. Inclusion in this directory is not an endorsement.