Hydroxychloroquine in Mild Graves' Orbitopathy

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Nov 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called hydroxychloroquine on patients with mild Graves' orbitopathy, a condition that affects the eyes and is associated with an overactive thyroid. The goal is to see if this medication can help improve symptoms in these patients. The study is currently looking for participants who are between the ages of 18 and 75 and have been diagnosed with mild Graves' orbitopathy by a doctor.

To be eligible for the trial, participants should not have had any treatments for their eye condition other than eye drops, and their thyroid hormone levels need to be stable for at least two months. However, people with more severe eye problems, those who are pregnant, or those with certain health issues (like kidney or liver problems) cannot take part in the study. Participants can expect to follow a specific treatment plan and attend regular check-ups to monitor their progress. Overall, this trial aims to find out if hydroxychloroquine can be beneficial for those dealing with mild symptoms of Graves' orbitopathy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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