Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients

NCT ID: NCT07085117

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-02

Study Completion Date

2025-08-10

Brief Summary

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The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.

Detailed Description

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A retrospective cohort will be followed retrospectively for endpoints at the only facility providing treatment of teprotumumab in mainland China. Eligible participants' data were collected retrospectively over a period of approximately 3 years. The target population is patients with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone. While the primary objective is to assess the proportion of patients with proptosis response as of the last intravenous infusion of teprotumumab, the secondary objectives are to describe baseline characteristics of patients at teprotumumab initiation, and the teprotumumab use at follow-up, to describe real-world effectiveness of clinical outcomes of interest, to describe patient-reported outcomes and to describe real-world safety of teprotumumab.

Conditions

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Thyroid Eye Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Teprotumumab

Participants with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone.

Teprotumumab

Intervention Type DRUG

Participants received teprotumumab as an intravenous (IV) infusion.

Interventions

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Teprotumumab

Participants received teprotumumab as an intravenous (IV) infusion.

Intervention Type DRUG

Other Intervention Names

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TEPEZZA®

Eligibility Criteria

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Inclusion Criteria

* Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
* Obtained study specific informed consent form (ICF), if required.

Exclusion Criteria

* Documentation of non-Chinese ethnicity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Boao Vanguard Hospital

Qionghai, Hainan, China

Site Status

Countries

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China

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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EUPAS1000000625

Identifier Type: OTHER

Identifier Source: secondary_id

20240345

Identifier Type: -

Identifier Source: org_study_id

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