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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2018 |
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Main ID: |
NCT01769001 |
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Date of registration:
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14/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Extension of a Phase 1/2, Open Label, Dose Ranging Study of PRX-102 in Adult Fabry Patients
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Scientific title:
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An Extension of Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 38 Weeks to Adult Fabry Patients |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01769001 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Australia
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Paraguay
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Einat Almon, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Protalix Biotherapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Completion of Phase 1/2 study PB-102-F01
- The patient signs informed consent
- Female patients and male patients whose co-partners are of child-bearing potential
agree to use a medically acceptable method of contraception, not including the rhythm
method
Exclusion Criteria:
- Pregnant or nursing
- Presence of any medical, emotional, behavioral or psychological condition that, in the
judgment of the Investigator and/or Medical Director, would interfere with the
patient's compliance with the requirements of the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fabry Disease
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Intervention(s)
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Drug: PRX-102
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Primary Outcome(s)
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Number of participants with adverse events as a measure of safety
[Time Frame: 38 weeks]
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Secondary Outcome(s)
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Pain
[Time Frame: 38 weeks]
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Proteinuria
[Time Frame: 38 weeks]
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Glomerular filtration rate
[Time Frame: 38 weeks]
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Gb3 concentrations
[Time Frame: 38 weeks]
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Secondary ID(s)
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PB-102-F02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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