---
title: "Hydroxychloroquine in Mild Graves' Orbitopathy"
nct_id: NCT05126147
overall_status: RECRUITING
phase: PHASE4
sponsor: National Taiwan University Hospital
study_type: INTERVENTIONAL
primary_condition: Graves Ophthalmopathy
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05126147.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05126147"
ct_last_update_post_date: 2025-02-25
last_seen_at: "2026-05-12T06:43:05.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hydroxychloroquine in Mild Graves' Orbitopathy

**Official Title:** A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

**NCT ID:** [NCT05126147](https://clinicaltrials.gov/study/NCT05126147)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** National Taiwan University Hospital
- **Conditions:** Graves Ophthalmopathy
- **Start Date:** 2022-03-21
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2025-02-25

## Brief Summary

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

## Detailed Description

Graves' orbitopathy (GO) is one of the common manifestations of Graves' disease (GD), which results in proptosis, eyelid retraction, soft tissue swelling, diplopia or even visual acuity impairment. In addition, mental health and quality of life are often affected. In current guidelines, limited treatment options are suggested for patients with mild GO.

Recently, cell study revealed that there are multiple effects of hydroxychloroquine (HCQ) on orbital fibroblasts in patients with mild GO, including suppression of cell proliferation, adipogenesis and production of hyaluronic acid, which poses a great potential in the treatment of mild GO clinically. This randomized controlled trial is aimed to investigate the effects of HCQ in patients with mild GO on the effects of ophthalmic outcomes, quality of life, orbital volumetry on orbital computed tomography, serum inflammatory and fibrosis markers.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Hydroxychloroquine** (EXPERIMENTAL) — Hydroxychloroquine 200mg twice daily for 6 months.
- **Control** (NO_INTERVENTION) — Observation and active surveillance.

## Interventions

- **Hydroxychloroquine** (DRUG) — Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.

## Primary Outcomes

- **The change of ophthalmic outcome** _(time frame: at 24 weeks and 48 weeks)_ — The ophthalmic outcome is a composite outcome which includes three components: eyelid aperture, soft tissue involvement and exophthalmos.

The outcome is defined as "improvement" if any of the three components improves without deterioration of any other components. The outcome of "deterioration" is defined if upgrading of soft tissue involvement or evidence of worsening sight or optic nerve compression. The outcome of "stable" is defined if the ophthalmic outcome does not fit the definition of "improvement" or "deterioration".

## Secondary Outcomes

- **The change of quality of life (GO-QoL)** _(time frame: at 24 weeks and 48 weeks)_
- **The change of muscle volume (cm^3) on computed tomography** _(time frame: at 24 weeks and 48 weeks)_
- **The change of fat volume (cm^3) on computed tomography** _(time frame: at 24 weeks and 48 weeks)_
- **The change of orbital volume (cm^3) on computed tomography** _(time frame: at 24 weeks and 48 weeks)_
- **The change of muscle density on computed tomography** _(time frame: at 24 weeks and 48 weeks)_
- **The change of fat density on computed tomography** _(time frame: at 24 weeks and 48 weeks)_
- **The change of diplopia score** _(time frame: at 24 weeks and 48 weeks)_
- **The change of clinical activity score (CAS)** _(time frame: at 24 weeks and 48 weeks)_
- **The change of visual acuity** _(time frame: at 24 weeks and 48 weeks)_
- **The change of antithyroid peroxidase antibody (anti-TPO) (IU/mL)** _(time frame: at 24 weeks and 48 weeks)_
- **The change of thyroglobulin antibody (TA) (IU/mL)** _(time frame: at 24 weeks and 48 weeks)_
- **The change of thyrotropin-binding inhibiting immunoglobulin (TBII) (%).** _(time frame: at 24 weeks and 48 weeks)_

## Locations (2)

- National Taiwan University Hospital, Hsin-Chu branch, Hsinchu, Taiwan — _RECRUITING_
- National Taiwan University Hospital, Taipei, Taiwan — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.national taiwan university hospital, hsin-chu branch|hsinchu||taiwan` — added _(2026-05-12)_
- `locations.national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_

---

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