Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
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ClinicalTrials.gov Identifier: NCT03018730 |
Recruitment Status :
Completed
First Posted : January 12, 2017
Last Update Posted : January 5, 2021
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Sponsor:
Protalix
Information provided by (Responsible Party):
Protalix
Tracking Information | |||||
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First Submitted Date ICMJE | January 9, 2017 | ||||
First Posted Date ICMJE | January 12, 2017 | ||||
Last Update Posted Date | January 5, 2021 | ||||
Actual Study Start Date ICMJE | February 23, 2017 | ||||
Actual Primary Completion Date | December 17, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Throughout the 12 months study ] | ||||
Original Primary Outcome Measures ICMJE |
Treatment-emergent anti-PRX-102 antibodies [ Time Frame: 12 months ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) | ||||
Official Title ICMJE | An Open Label Study of the Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) | ||||
Brief Summary | This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80% labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3 months while continuing on agalsidase alfa. Following the screening period, the patient will be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated patients will be female. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Fabry Disease | ||||
Intervention ICMJE | Biological: PRX-102 (pegunigalsidase alfa)
PRX-102 1 mg/kg every 2 weeks
Other Names:
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Study Arms ICMJE | Experimental: PRX-102
PRX-102 infusion every 2 weeks
Intervention: Biological: PRX-102 (pegunigalsidase alfa)
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 17, 2019 | ||||
Actual Primary Completion Date | December 17, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Canada, Czechia, Germany, Netherlands, Norway, Slovenia, Spain, United Kingdom | ||||
Removed Location Countries | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03018730 | ||||
Other Study ID Numbers ICMJE | PB-102-F30 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Protalix | ||||
Study Sponsor ICMJE | Protalix | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Protalix | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |