Hydroxychloroquine in Mild Graves' Orbitopathy

Recruiting now · Phase 4

Conditions studied: Graves Ophthalmopathy

In brief

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

Key facts

Study ID

NCT05126147

Run by

National Taiwan University Hospital

People needed

108

Starts

2022-03-21

Expected to finish

2026-12-31

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• National Taiwan University Hospital, Hsin-Chu branch — Hsinchu, Taiwan (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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