Clincosm LogoSign in Get a demo

CLOZARIX: Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database

Sponsor
University Hospital, Caen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04074213
Collaborator
(none)
1,000,000
Enrollment
1
Location
65.1
Anticipated Duration (Months)
15372.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Condition or Disease Intervention/Treatment Phase

Detailed Description

Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Clozapine and Haematologic Malignancies: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Haematologic malignancies with clozapine

Cases reported in the World Health Organization (WHO) database of patients treated by Clozapine, with a chronology compatible with the drug toxicity

Drug: Clozapine
Clozapine treatment
Other Names:
  • Clozapine treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®. [Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]]

      Study the correlation between clozapine and haematologic malignancies by comparing the proportion of Individual Case Reports (ICSRs) of hematologic malignancies with liable clozapine with the proportion of ICSRs of hematologic malignancies with at least one liable antipsychotic.

    Secondary Outcome Measures

    1. investigate a potential dose-dependent effect [Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]]

      To investigate a potential dose-dependent effect, we will collect the clozapine daily dose from all clozapine ICSRs. In ICSRs with liable clozapine, the clozapine daily dose in mg will be divided into quartiles. A disproportionality analysis will be performed to evaluate the effect of the clozapine daily dose on the reporting of lymphomas and leukaemia. A significant difference of proportion of reports of haematologic malignancies between each quartile will be researched.

    2. Description of the clinical features of clozapine-related haematologic malignancies [Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]]

      Description of the clinical features (mean age, sex ratio, time to onset, daily dose) of clozapine-related haematologic malignancies according to the main clinical subtypes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019

    • Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)

    • Patients treated with at least one liable antipsychotic drug (ATC class N05A)

    Exclusion Criteria:
    • Chronology not compatible between the drug and the toxicity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital, Department of Pharmacology Caen Normandie France 14033

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Basile Chrétien, PharmD, MSc, University Hospital, Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT04074213
    Other Study ID Numbers:
    • 19-916
    First Posted:
    Aug 30, 2019
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Clozapine

    Study Results

    No Results Posted as of Aug 30, 2019