RecruitingPhase 4NCT05126147

Hydroxychloroquine in Mild Graves' Orbitopathy

A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

Sponsor

National Taiwan University Hospital

Enrollment

108 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

Min Age: 18 YearsMax Age: 75 Years

Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist.
No previous treatment of GO except for eyedrops
Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months.

Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist.
Pregnancy
Drug or alcohol abuse
Unable to comply with the study protocol
Unable to obtain informed consent
Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment
History of side effects of hydroxychloroquine
History of retinopathy
Renal dysfunction (estimated glomerular filtration rate (eGFR) \< 60ml/min)
Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit)
Anemia (hemoglobin (Hb) \< 10g/dl)
Neutropenia (absolute neutrophil count \< 100/uL)
Thrombocytopenia (platelet (PLT) \< 150000/uL)
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Porphyria cutaneous tarda
Allergy to 4-aminoquinoline