Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients
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ClinicalTrials.gov Identifier: NCT04552691 |
Expanded Access Status :
Available
First Posted : September 17, 2020
Last Update Posted : March 31, 2023
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Sponsor:
Chiesi Farmaceutici S.p.A.
Collaborator:
Chiesi USA, Inc.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
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Tracking Information | |||||
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First Submitted Date | September 11, 2020 | ||||
First Posted Date | September 17, 2020 | ||||
Last Update Posted Date | March 31, 2023 | ||||
Descriptive Information | |||||
Brief Title | Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients | ||||
Brief Summary | The objective of this treatment protocol is to provide guidance to Treating Physicians who seek access to pegunigalsidase alfa for Fabry patients whose clinical condition, in the opinion of the Treating Physician, requires treatment with enzyme replacement therapy (ERT) with pegunigalsidase alfa and a) cannot be adequately treated with currently approved FDA products and/or b) are not able or willing to participate in any of the on-going clinical trials in the United States. | ||||
Detailed Description | Not Provided | ||||
Study Type | Expanded Access | ||||
Expanded Access Type | Intermediate-size Population | ||||
Intervention | Drug: Pegunigalsidase Alfa
Pegunigalsidase alfa is a recombinant ERT (enzyme replacement therapy) used to treat Fabry disease (dosage: 1 mg/kg body weight every 2 weeks).
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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 | |||||
Expanded Access Status | Available | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04552691 | ||||
Current Responsible Party | Chiesi Farmaceutici S.p.A. | ||||
Original Responsible Party | Protalix | ||||
Current Study Sponsor | Chiesi Farmaceutici S.p.A. | ||||
Original Study Sponsor | Protalix | ||||
Collaborators | Chiesi USA, Inc. | ||||
Investigators | Not Provided | ||||
PRS Account | Chiesi Farmaceutici S.p.A. | ||||
Verification Date | March 2023 |