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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: Completed Phase 1 study, sponsored by Protalix.
NCT01678898 is a Phase 1 study that has completed, run by Protalix. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reportings of adverse events reported by the patient and from monitoring with clinical laboratory, physical examination and ECG. Results represent the number of AEs that were considered possibly, probably, or definitely related to treatment.
Interventions
- DRUG PRX-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-03-06 |
| Phase | Phase 1 |
What the finished NCT01678898 record still lists
NCT01678898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which PRX-102 is the first listed.
NCT01678898 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01678898's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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