Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheba Medical Center
About this trial
The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).
The main question it aims to answer is:
\* Is a shorter course equally effective and safe for patients who respond well early in treatment.
Participants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.
Eligibility criteria
Qualifiers
Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).
Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.
Participants must demonstrate a significant clinical response by the 4th infusion.
Ability to understand and provide signed written informed consent.
Disqualifiers
Previous use of Teprotumumab or other biologic therapies for TED.
Participants who do not show early clinical response after the 4th infusion.
Participants who have any medical contraindications to Teprotumumab or any of its components.
Participants who have any known hearing problems.
Trial design
Treatments tested in this trial
- Teprotumumab Injection [Tepezza]
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov