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NCT02797080 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT02797080: Completed Phase 3 study, sponsored by Amgen.
NCT02797080 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02797080, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the investigational product. A TEAE is any adverse change from the subject's baseline condition, including any laboratory test value abnormality judged as clinically significant by the investigator, that occurs on or after the date of the first dose of study drug administered at home and throughout the duration of the clinical study, whether the adverse event is considered related to the t
Interventions
- DRUG interferon γ-1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-06-28 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 3 |
What the finished NCT02797080 record still lists
NCT02797080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which interferon γ-1b is the first listed.
NCT02797080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02797080 about?
NCT02797080 is a clinical study titled "Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia". The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
What is the current status of trial NCT02797080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2016-06-28. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02797080?
The interventions under investigation include: interferon γ-1b (DRUG).
Who is sponsoring clinical trial NCT02797080?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02797080's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 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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