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NCT02613182 · ClinicalTrials.gov registry record · Phase 2
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
A Phase 2 study, sponsored by Prothena Biosciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT02613182: Clinical Trial Phase 2 study, sponsored by Prothena Biosciences.
NCT02613182 is a Phase 2 study that was terminated before completion, run by Prothena Biosciences. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613182, a Phase 2 study, was terminated before completion, sponsored by Prothena Biosciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.
Primary Outcome
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth
Interventions
- DRUG NEOD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-05 |
| Phase | Phase 2 |
Why NCT02613182 stopped before completion
NCT02613182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which NEOD001 is the first listed.
NCT02613182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02613182 about?
NCT02613182 is a clinical study titled "Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis". The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.
What is the current status of trial NCT02613182?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2016-02. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02613182?
The interventions under investigation include: NEOD001 (DRUG).
Who is sponsoring clinical trial NCT02613182?
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 NCT02613182's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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