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New treatment option for Graves Ophthalmopathy
Official title Hydroxychloroquine in Mild Graves' Orbitopathy
ClinicalTrials.gov ID: NCT05126147
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, given as an once-daily, being studied as a potential treatment for graves ophthalmopathy.
Also referred to as Plaquenil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
You likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hsinchu, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hsinchu, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.