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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 is a Phase 1 study that was terminated before completion, run by Prothena Biosciences Limited. The registered enrollment target is 21 participants.
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.
Interventions
- DRUG PRX004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03336580
The ClinicalTrials.gov registry entry for NCT03336580 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prothena Biosciences Limited, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PRX004 is the first listed.
NCT03336580 reports 0 study locations.
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.
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