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NCT Number: NCT03994302

Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

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).

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Key information

Conditions

Antiphospholipid Syndrome Adverse Drug Event Autoimmune Diseases Chemically-Induced Disorders Drug Toxicity Drug-Related Side Effects and Adverse Reactions Immune Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug inducing antiphospholipid syndrome

Drug

Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Primary outcomes

  1. Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.

    Time frame: 01/06/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary outcomes

  1. 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

    Time frame: 01/06/2019

  2. 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

    Time frame: 01/06/2019

  3. 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

    Time frame: 01/06/2019

  4. 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

    Time frame: 01/06/2019

  5. Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports

    Time frame: 01/06/2019

  6. 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

    Time frame: 01/06/2019

  7. 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

    Time frame: 01/06/2019

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: APSTOX

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jun 21, 2019
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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