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A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

Last updated on October 6, 2018

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Study Location
Contact
1-800-718-1021
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

- Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003

- The subject signs an informed consent

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

- Currently taking another investigational drug for any condition.

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

NCT01422187
Pfizer
Completed
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

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Similar Trials

A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (?18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gaucher Disease
Drug: Taliglucerase alfa
Taliglucerase infusion every two weeks for 21 months
  • Experimental: Taliglucerase alfa 30 units/kg
    Subjects randomized to receive 30 units/kg
    Intervention: Drug: Taliglucerase alfa
  • Experimental: Taliglucerase alfa 60 units/kg
    Subjects randomized to 60 units/kg
    Intervention: Drug: Taliglucerase alfa
Zimran A, Durán G, Giraldo P, Rosenbaum H, Giona F, Petakov M, Terreros Muñoz E, Solorio-Meza SE, Cooper PA, Varughese S, Alon S, Chertkoff R. Long-term efficacy and safety results of taliglucerase alfa through 5years in adult treatment-naïve patients with Gaucher disease. Blood Cells Mol Dis. 2016 Jul 18. pii: S1079-9796(16)30087-0. doi: 10.1016/j.bcmd.2016.07.002. [Epub ahead of print]


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
25
September 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
  • The subject signs an informed consent

Exclusion Criteria:

  • Currently taking another investigational drug for any condition.
  • Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject'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
Not Provided
 
 
NCT01422187
PB-06-007
No
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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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