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Genetic Study of Antithyroid Drugs Associated Agranulocytosis

NCT ID: NCT01977963

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side effects are found in 1% - 5% of the patients1. One of the most serious side effect is agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon may be involved because the antigranulocyte antibodies or lymphocyte sensitized to antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility complex class II peptide complexes by T lymphocytes is central to the development of immune response. According to a report in 1996, the HLA DRB1\*08032 allele is strongly associated with susceptibility to methimazole-induced agranulocytosis20.

Recently, there are new techniques for genetics study. We aimed to identify the associated genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP. If no significant change is found in the above genes, we will consider whole exon sequencing with next-generation sequencing, Statistic analysis will include appropriate linkage analysis, association study, variation data analysis, pathway analysis. If we can identify the genetic change and perform genetic examinations before prescription, we can avoid the happening of severe side effects.

Detailed Description

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Conditions

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Agranulocytosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Agranulocytosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients with absolute neutrophil count lower than 500/mm3 caused by anti-thyroid drugs

Exclusion Criteria

* Patients who is younger than 20 years old or older than 85 years old
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Shyang-Rong Shih, PhD

Role: primary

Other Identifiers

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201112083RID

Identifier Type: -

Identifier Source: org_study_id