Genetic Study of Antithyroid Drugs Associated Agranulocytosis

NCT01977963 | Unknown

• 1 other identifier: 201112083RID
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Agranulocytosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with anti-thyroid drug related agranulocytosis

  The investigators review the chart to see if the patients had anti-thyroid drug related agranulocytosis

  within 2 month after taking the drug

Study Arms (1)

Agranulocytosis

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Agranulocytosis caused by anti-thyroid drugs

You may qualify if:

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

You may not qualify if:

• Patients who is younger than 20 years old or older than 85 years old

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Agranulocytosis

Condition Hierarchy (Ancestors)

Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: April 1, 2012
• Primary Completion: January 1, 2022
• Last Updated: November 7, 2013

Record last verified: 2013-10

Locations

TW (1)