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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03994302
Other study ID # CIC1421-19-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date April 8, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).


Description:

Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents. This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.


Recruitment information / eligibility

Status Completed
Enrollment 2700
Est. completion date April 8, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Case reported in the WHO's pharmacovigilance database till 01/06/2019 Exclusion Criteria: - Chronology not compatible between the drug and the toxicity

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Drug inducing antiphospholipid syndrome
Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Locations

Country Name City State
France AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs. Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
Secondary Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports 01/06/2019
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