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Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

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NCT00705939

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Department of Human Genetics, Emory University School of Medicine
Decatur, Georgia, 30033 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gaucher Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Successful completion of Protocol PB-06-001

- The patient signs informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Currently taking another experimental drug for any condition

- Presence of severe neurological signs and symptoms, defined as complete ocular
paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic
Gaucher disease

- Pregnant or nursing

- Presence of any medical, emotional, behavioral or psychological condition that in the
judgment of the Investigator would interfere with the patient's compliance with the
requirements of the study

NCT00705939
Pfizer
Completed
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

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Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
A Multicenter, Double-Blind, Extension Trial of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is an extension trial to Study NCT00376168 and NCT00712348.
This will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prGCD in patients completing NCT00376168. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the extension study will be fifteen months. There will be two treatment groups: 30 units/kg every 2 weeks or 60 units/kg every 2 weeks.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gaucher Disease
Drug: Taliglucerase alfa
Intravenous infusion every 2 weeks
Other Names:
  • Plant Cell Expressed Recombinant Human Glucocerebrosidase
  • prGCD
  • Experimental: Naive 30 Units/kg
    Continue taliglucerase alfa treatment from PB-06-001 (NCT00376168)
    Intervention: Drug: Taliglucerase alfa
  • Experimental: Naive 60 Units/kg
    Continue taliglucerase alfa treatment from PB-06-001 (NCT00376168)
    Intervention: Drug: Taliglucerase alfa
  • Experimental: Switchover
    Continue taliglucerase alfa treatment from PB-06-002 (NCT00712348)
    Intervention: Drug: Taliglucerase alfa


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
25
August 2013
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of Protocol PB-06-001
  • The patient signs informed consent

Exclusion Criteria:

  • Currently taking another experimental drug for any condition
  • Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
  • Pregnant or nursing
  • Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Chile,   Israel,   South Africa,   Spain,   United Kingdom,   United States
 
 
NCT00705939
PB-06-003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Not Provided
Pfizer
September 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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