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NCT04973137 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
A Phase 3 study, sponsored by Prothena Biosciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
NCT04973137: Clinical Trial Phase 3 study, sponsored by Prothena Biosciences.
NCT04973137 is a Phase 3 study that was terminated before completion, run by Prothena Biosciences. The registered enrollment target is 208 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973137, a Phase 3 study, was terminated before completion, sponsored by Prothena Biosciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
Study Summary
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Primary Outcome
Comparison of time to all-cause mortality for birtamimab and placebo control.
Interventions
- OTHER Placebo
- DRUG Standard of Care Chemotherapy
- DRUG Birtamimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2025-06-20 |
| Phase | Phase 3 |
Why NCT04973137 stopped before completion
NCT04973137 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04973137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04973137 about?
NCT04973137 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis". A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
What is the current status of trial NCT04973137?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2021-08-30. Estimated completion is 2025-06-20.
What interventions are being tested in trial NCT04973137?
The interventions under investigation include: Placebo (OTHER), Standard of Care Chemotherapy (DRUG), Birtamimab (DRUG).
Who is sponsoring clinical trial NCT04973137?
This trial is sponsored by Prothena Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04973137's enrollment target sits among peer trials
208 1345th of 2000 higher than 655 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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