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NCT03461211 · ClinicalTrials.gov registry record · Phase 3
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT03461211 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 51 participants.
The verdict
NCT03461211, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were either proptosis non-responders at Week 24 of HZNP-TEP-301 or were proptosis responders at Week 24 but met the criteria for re-treatment due to relapse during the Follow-Up Period of HZNP-TEP-301.
Interventions
- BIOLOGICAL Teprotumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2021-02-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03461211
The ClinicalTrials.gov registry entry for NCT03461211 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Teprotumumab is the first listed.
NCT03461211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03461211 about?
NCT03461211 is a clinical study titled "Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study". The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were either proptosis non-responders at Week 24 of HZNP-TEP-301 or were proptosis...
What is the current status of trial NCT03461211?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2018-04-16. Estimated completion is 2021-02-17.
What interventions are being tested in trial NCT03461211?
The interventions under investigation include: Teprotumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03461211?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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