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Genetic Study of Antithyroid Drugs Associated Agranulocytosis

This study is currently recruiting participants.
Verified October 2013 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01977963
First Posted: November 7, 2013
Last Update Posted: November 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose

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.


Condition
Agranulocytosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Study of Antithyroid Drugs Associated Agranulocytosis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Number of participants with anti-thyroid drug related agranulocytosis [ Time Frame: within 2 month after taking the drug ]
    The investigators review the chart to see if the patients had anti-thyroid drug related agranulocytosis


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Agranulocytosis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Agranulocytosis caused by anti-thyroid drugs
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977963


Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shyang-Rong Shih, PhD    886-972653337    srshih@ntu.edu.tw   
Principal Investigator: Shyang-Rong Shih, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01977963     History of Changes
Other Study ID Numbers: 201112083RID
First Submitted: October 31, 2013
First Posted: November 7, 2013
Last Update Posted: November 7, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs