Using hydroxychloroquine to treat mild Graves' orbitopathy
A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy
This study is testing if hydroxychloroquine can help people with mild Graves' orbitopathy feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 2 sites (Hsinchu and 1 other locations) |
| Trial ID | NCT05126147 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of hydroxychloroquine (HCQ) on patients with mild Graves' orbitopathy (GO), a condition associated with Graves' disease that can lead to various eye-related symptoms and impact quality of life. The study aims to assess ophthalmic outcomes, quality of life, and changes in orbital volume through computed tomography, as well as serum inflammatory and fibrosis markers. Patients will be randomized to receive HCQ, with the goal of determining its efficacy in managing mild GO symptoms. The trial follows strict eligibility criteria to ensure the safety and appropriateness of participants.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild Graves' orbitopathy who have not received prior treatment except for eyedrops.
Not a fit: Patients with moderate-to-severe or sight-threatening Graves' orbitopathy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from mild Graves' orbitopathy.
How similar studies have performed: While the use of hydroxychloroquine in this context is novel, preliminary cell studies suggest potential efficacy, but further clinical validation is needed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hsinchu and 1 other locations
- National Taiwan University Hospital, Hsin-Chu branch — Hsinchu, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shyang-Rong Shih
- Email: srshih@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.