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Extension Study of PRX-102 for up to 60 Months

NCT01981720 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-13

Study results available
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Summary

To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

Conditions

Interventions

BIOLOGICAL

PRX-102 (pegunigalsidase alfa)

PRX-102 1 mg/kg every 2 weeks

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY

  • Protalix

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-16
Primary Completion
2020-08-26
Completion
2021-11-09
FDA Drug
Yes

Countries

  • United States
  • Paraguay
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981720 on ClinicalTrials.gov