The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
1 other identifier
interventional
40
1 country
1
Brief Summary
Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation of thyroid gland and destroys thyroid tissue. Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis(RA) for more than one century. The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment of Hashimoto's thyroiditis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 23, 2014
April 1, 2014
1.2 years
October 20, 2011
April 22, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Anti-TPO antibody
Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
6th month after medical treatment
Anti-thyroglobulin antibody
Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
6 months after medical treatment
Secondary Outcomes (3)
Elasticity of thyroid gland
6 months after medical treatment
Thyroid function
6 months after medical treatment
Inflammatory cytokines
6 months after treatment
Study Arms (1)
Hydroxychloroquine
EXPERIMENTALReceive treatment with hydroxychloroquine
Interventions
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Eligibility Criteria
You may qualify if:
- Hashimoto's thyroiditis
- Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit)
- Never receive immunomodulators or immunosuppressants
You may not qualify if:
- Planned pregnant or already pregnant women
- Renal insufficiency
- Hepatic insufficiency
- Anemia
- Agranulocytosis
- Thrombocytopenia
- Glucose-6-phosphate dehydrogenase deficiency
- Porphyria cutaneous tarda
- Allergy to 4-aminoquinolone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tien-Shung Huang, Ph.D.
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2011
First Posted
January 4, 2013
Study Start
October 1, 2011
Primary Completion
December 1, 2012
Study Completion
August 1, 2013
Last Updated
April 23, 2014
Record last verified: 2014-04