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NCT02175004 · ClinicalTrials.gov registry record · Phase 3
Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
A Phase 3 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT02175004: Completed Phase 3 study, sponsored by Ionis Pharmaceuticals.
NCT02175004 is a Phase 3 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02175004, a Phase 3 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.
Primary Outcome
An adverse event (AE) is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose that results in death, is life
Interventions
- DRUG Inotersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2014-06-26 |
| Est. Completion | 2021-01-07 |
| Phase | Phase 3 |
What the finished NCT02175004 record still lists
NCT02175004 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Inotersen is the first listed.
NCT02175004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02175004 about?
NCT02175004 is a clinical study titled "Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)". This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.
What is the current status of trial NCT02175004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2014-06-26. Estimated completion is 2021-01-07.
What interventions are being tested in trial NCT02175004?
The interventions under investigation include: Inotersen (DRUG).
Who is sponsoring clinical trial NCT02175004?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02175004's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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