- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005307
Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused by drugs and other environmental factors. In 1980, there were only limited quantitative estimates of the risk between various exposures, particularly drugs, and the two dyscrasias. The data were collected in the IAAAS, a multicenter population-based case-control study conducted from 1980 to 1986 in eight regions. The study was funded by a pharmaceutical company to investigate a single hypothesis, but information was obtained on all drugs and on other factors, enabling a general investigation of the dyscrasias.
DESIGN NARRATIVE:
The study was for retrospective data analysis only. Standard case-control methods were used. In most instances, multivariate analysis was used to control confounding, especially by simultaneous use of other causal drugs. Adverse effects and the relative safety of drugs in relation to the two dyscrasias were documented. Because the IAAAS was population-based, incidence rates were provided directly, and excess risks were estimated for associated drugs. Such quantitative measures of association were generally unavailable. Among the drugs that were analyzed were various categories such as psychotropics, antihistamines, and cardiovascular drugs, and individual drugs such as allopurinol. Factors other than drugs were also evaluated, including exposure to radiation and chemicals such as benzene and insecticides, history of viral infection, and history of allergy and other conditions.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3009
- R01HL042524 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Agranulocytosis
-
National Taiwan University HospitalUnknown
-
Mayne Pharma International Pty LtdCompleted
-
Hospital Regional de Alta Especialidad del BajioUniversidad de GuanajuatoCompleted
-
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,The First Affiliated Hospital with Nanjing Medical University; Cancer Institute... and other collaboratorsUnknown
-
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,Cancer Institute and Hospital, Chinese Academy of Medical SciencesUnknown
-
AmgenCompleted
-
University Hospital, Strasbourg, FranceRecruiting
-
Merck Sharp & Dohme LLCCompleted
-
Affiliated Hospital of North Sichuan Medical CollegeUnknown
-
St. Justine's HospitalNancy Robitaille, MDTerminated