thyroid eye disease
Conditions
Interventions
Teprotumumab treatment group:Teprotumumab treatment
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All patients were intended to be treated with Teprotumumab and signed written informed consent. 2. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 3 × Upper Limit of Normal (ULN), and Serum Creatinine < 1.5 × ULN; 3. Diabetic subjects must be well-controlled and clinically stable (defined as HbA1c < 9.0%). 4. Patients willing and able to comply with study follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Biopsy confirmed or clinically suspected inflammatory bowel disease (IBD) (e.g., diarrhea with or without blood) or rectal bleeding accompanied by symptoms such as abdominal pain/cramping, urgency, tenesmus, persisting for more than 4 weeks. 3. Known prior severe hypersensitivity to investigational product or any component in its formulations. 4. Any other criteria for which the investigator deems patients unsuitable for this present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proptosis response in teprotumumab group.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Diplopia ;Blood and Serological Biomarkers During Treatment Course;Absolute change in proptosis from baseline ;Total Ophthalmic Response Rate;Proportion of subjects achieving Clinical Activity Score (CAS) 0/1 ;Adverse Events Monitoring During Treatment;Long-term Efficacy and Safety Assessment of Teprotumumab Post-Treatment Cessation;Composite Ocular Efficacy Endpoint; | — |
Countries
China
Contacts
Public ContactTingting Lin
Tianjin Medical University Eye Hospital
Outcome results
None listed