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Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease

NCT04040894 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

  • Thyroid Eye Disease
  • Graves' Orbitopathy

Interventions

BIOLOGICAL

Teprotumumab

Treatment with 8 infusions of Teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg will be administered on Day 1 and Teprotumumab 20 mg/kg will be administered q3W for the remaining 7 infusions.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040894 on ClinicalTrials.gov