CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Taliglucerase alfadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01132690
NCT01132690Phase 4Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Pfizer·interventional·Posted May 28, 2010·Updated Oct 5, 2018

In Brief

A Phase 4 clinical trial evaluating Taliglucerase alfa for Gaucher Disease. Completed, enrolled 11 participants across 3 sites in 3 countries.

Detailed Summary

This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to \<18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesIsrael, Paraguay, South Africa
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago

Interventions

Taliglucerase alfadrug

Taliglucerase alfa for infusion every two weeks for 12 months