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Clinical Trial Summary

This is an expanded access protocol intended to provide access to teprotumumab for the treatment of up to 60 patients in the United States with active moderate to severe thyroid eye disease where there is no comparable or satisfactory alternative therapy for treatment.


Clinical Trial Description

Requests for access to the Sponsor must be made by a licensed physician for a specific patient, based on a determination with the patient that the benefits of treatment with the investigational drug outweigh the risks. Licensed physician's with eligible patients must apply and meet requirements for participation in the expanded access program. Study acquired from Horizon in 2024. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04040894
Study type Expanded Access
Source Amgen
Contact
Status Approved for marketing
Phase

See also
  Status Clinical Trial Phase
Completed NCT04583735 - A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease Phase 4
Active, not recruiting NCT05002998 - TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study Phase 4
Withdrawn NCT02422368 - The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease Phase 2/Phase 3
Completed NCT03298867 - Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Phase 3
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Not yet recruiting NCT06401044 - A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease Phase 1
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