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NCT01678898 · ClinicalTrials.gov registry record · Phase 1

Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

A Phase 1 study, sponsored by Protalix.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT01678898 is a Phase 1 study that has completed, run by Protalix. The registered enrollment target is 18 participants.

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The verdict

NCT01678898, a Phase 1 study, has completed, sponsored by Protalix.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

Interventions

  • DRUG PRX-102

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2012-10
Est. Completion 2016-03-06
Phase Phase 1

Sponsor

Protalix

5 total trials

What the Registry Record Tells You About NCT01678898

The ClinicalTrials.gov registry entry for NCT01678898 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protalix, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PRX-102 is the first listed.

NCT01678898 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01678898 about?

NCT01678898 is a clinical study titled "Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients". This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasi...

What is the current status of trial NCT01678898?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-10. Estimated completion is 2016-03-06.

What interventions are being tested in trial NCT01678898?

The interventions under investigation include: PRX-102 (DRUG).

Who is sponsoring clinical trial NCT01678898?

This trial is sponsored by Protalix, which has 5 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.