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NCT03336580 · ClinicalTrials.gov registry record · Phase 1
A Study of PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis
A Phase 1 study, sponsored by Prothena Biosciences Limited.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03336580: Clinical Trial Phase 1 study, sponsored by Prothena Biosciences Limited.
NCT03336580 is a Phase 1 study that was terminated before completion, run by Prothena Biosciences Limited. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03336580, a Phase 1 study, was terminated before completion, sponsored by Prothena Biosciences Limited.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
A Phase 1, open-label study of intravenous (IV) PRX004 as a single agent in subjects with hereditary amyloid transthyretin (hATTR) amyloidosis. The study will consist of 3 phases and will enroll up to a total of 36 subjects. A 3+3 dose escalation component to determine the safety, tolerability, PK, PD, and MTD. An expansion component in anticipated PRX004 RP2D cohorts selected from the Dose Escalation Phase. An extended dosing component for eligible subjects from the Dose Escalation or Expansion phases.
Primary Outcome
Maximum Tolerated Dose of PRX004
Interventions
- DRUG PRX004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 1 |
Why NCT03336580 stopped before completion
NCT03336580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which PRX004 is the first listed.
NCT03336580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03336580 about?
NCT03336580 is a clinical study titled "A Study of PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis". A Phase 1, open-label study of intravenous (IV) PRX004 as a single agent in subjects with hereditary amyloid transthyretin (hATTR) amyloidosis. The study will consist of 3 phases and will enroll up to a total of 36 subjects. A 3+3 dose escalation component to determine the safety, tolerability, PK, ...
What is the current status of trial NCT03336580?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-04-05. Estimated completion is 2020-07-23.
What interventions are being tested in trial NCT03336580?
The interventions under investigation include: PRX004 (DRUG).
Who is sponsoring clinical trial NCT03336580?
This trial is sponsored by Prothena Biosciences Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03336580's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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