Trials / Completed
CompletedNCT03994302
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,700 (actual)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug inducing antiphospholipid syndrome | Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2021-06-30
- Completion
- 2023-04-08
- First posted
- 2019-06-21
- Last updated
- 2023-04-13
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03994302. Inclusion in this directory is not an endorsement.