Hydroxychloroquine in Mild Graves' Orbitopathy
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT05126147
- Record updated
- 2 November 2026
- Original description
This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).Read full original descriptionShow less
A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy
This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
Inclusion: 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.
Exclusion: Drug or alcohol abuse; Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment; History of side effects of hydroxychloroquine; History of retinopathy; Allergy to 4-aminoquinoline; 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; Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist; Pregnancy; Unable to comply with the study protocol; Unable to obtain informed consent; Porphyria cutaneous tarda.