Pilot study of SOM230 for Treatment of Graves’ Ophthalmopathy

Yonsei University Health System, Severance Hospital0 sites20 target enrollmentStarted: TBDLast updated: March 11, 2019

Overview

No summary available.

•1\. Male or female patients between 18 and 80 years of age
•2\. Patients with active GO demonstrated by
•\- Clinical activity score \>3
•\- Patient who have shown at least one symptom and sign within one of the NOSPECS class 2, 3 and 4
•\- Abnormal value of TSH receptor antibody (IU/L) : evidence of Graves’ disease
•3\. Patients with a known history of failure to respond to glucocorticoid treatment for control of active inflammation of GO may be included
•4\. Patients with stable euthyroidism are required. Patients who are in medication of antithyroid drugs (carbimazole, benzylthiouracil, and propylthiouracil) may be included, as long as the dosage is not significantly modified during the study.
•5\. Patients with topical products (articial tears, ocular lubricants, and antibiotic eye drops) may be included.
•6\. Patients who underwent thyroidectomy and are given exogenous T4 at the appropriate dosage are permitted.
•7\. Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication.

•1\. Illiteracy, Foreigner who can't understand Korean language
•2\. Patients who have being treated with systemic steroids, or other immunosuppressive agents within the previous 4 weeks.
•3\. Patients who have undergone eye/orbital surgery/ surgical therapy for any cause within 1 months
•4\. Patients who are being or were treated with octreotide, lanreotide or dopamine agonist and who have received pasireotide (SOM230\) prior to this study
•5\. Patients who have received orbital radiotherapy within the previous 4 weeks
•6\. Patients who are not in active inflammatory state (CAS 3 or less) of GO
•7\. Patients who are presenting typical symptoms and signs of GO, but are not presenting symptoms and signs of Graves’ disease or not having abnormal value of anti\-thyroid antibody such as TSH receptor antibody (no evidence of Graves’ disease)
•8\. Patients with symptomatic chlelithiasis
•9\. Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by Hb1ac \>8%
•10\. Patients with abnormal coagulation (PT and /or aPTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (protrombin time) or aPTT (activated partial thromboplasin time)

Sponsor