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NCT01981720 · ClinicalTrials.gov registry record · Phase 1
Extension Study of PRX-102 for up to 60 Months
A Phase 1 study, sponsored by Protalix.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01981720: Completed Phase 1 study, sponsored by Protalix.
NCT01981720 is a Phase 1 study that has completed, run by Protalix. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981720, a Phase 1 study, has completed, sponsored by Protalix.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment.
Interventions
- BIOLOGICAL PRX-102 (pegunigalsidase alfa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-01-16 |
| Est. Completion | 2021-11-09 |
| Phase | Phase 1 |
What the finished NCT01981720 record still lists
NCT01981720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which PRX-102 (pegunigalsidase alfa) is the first listed.
NCT01981720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01981720 about?
NCT01981720 is a clinical study titled "Extension Study of PRX-102 for up to 60 Months". 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.
What is the current status of trial NCT01981720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-01-16. Estimated completion is 2021-11-09.
What interventions are being tested in trial NCT01981720?
The interventions under investigation include: PRX-102 (pegunigalsidase alfa) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01981720?
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 NCT01981720's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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