Hydroxychloroquine in Graves' Orbitopathy

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Mild or moderate-to-severe GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist. Three categories of participants are included:

1. Mild GO

2. Active moderate-to-severe GO with contraindication to glucocorticoid

3. Inactive moderate-to-severe GO

• 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 Criteria:

• 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