Clinical trials: Pharmacovigilance
Atrial Fibrillation
Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database
Atrial fibrillation is the most prevalent sustained arrhythmia worldwide with a great morbimortality. Some populations are more at risk to develop atrial fibrillation like patients suffering from inflammatory diseases or patients…
- Trial name
- NCT06095791
- Testing
- Immunomodulators with FDA approval on the 1st January 2023.
- Where
- France
- Volunteers
- 4,000,000 people
- Sponsor
- University Hospital, Caen
Malaria in Pregnancy, Pregnancy Related
MiMBa Pregnancy Registry
The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester.
- Conditions
- Malaria in Pregnancy, Pregnancy Related, Congenital Anomaly
- Trial name
- NCT04825782
- Where
- 2 sites in Burkina Faso, Kenya
- Volunteers
- 15,391 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Multiple Sclerosis, Malignant Tumor
Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
Even though the therapeutic panel for multiple sclerosis (MS) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking.
- Trial name
- PVSEPK (NCT04237337)
- Testing
- Exposure to MS drugs
- Volunteers
- 200,000 people
- Sponsor
- University Hospital, Caen
Adverse Drug Reaction (ADR)
The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy
The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in…
- Trial name
- INTEGRATE (NCT06822959)
- Testing
- Pharmacogenetics, TDM and MedReview
- Where
- 2 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Direzione centrale salute, politiche sociali e disabilità
Heart Failure, Cancer, Therapy-Related
Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study
Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular…
- Trial name
- NCT06268535
- Testing
- Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023
- Where
- France
- Volunteers
- 36,580,288 people
- Sponsor
- University Hospital, Caen
Cancer, Side Effect of Drug
Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety
Little is known about cancer therapy-related radiopharmaceuticals drugs safety. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to…
- Trial name
- RADIANTS (NCT06483685)
- Testing
- Radiopharmaceuticals drugs
- Where
- France
- Volunteers
- 500,000 people
- Sponsor
- University Hospital, Caen
Cancer
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy…
- Trial name
- AVATAR (NCT04696250)
- Testing
- Antineoplastic and Immunomodulating Agents
- Where
- France
- Volunteers
- 5,000,000 people
- Sponsor
- University Hospital, Caen
Melanoma
Yervoy Pregnancy Surveillance Study
The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age
- Trial name
- NCT02854488
- Testing
- Yervoy
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Torsades de Pointe Caused by Drug
A Pharmacovigilance Study of Torsade de Pointes
Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death.
- Trial name
- NCT04293432
- Testing
- Drugs, Generic
- Where
- Pakistan
- Volunteers
- 6,670 people
- Sponsor
- University of Peshawar
Malignancies, Cardiovascular Diseases
Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies
Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies.
- Conditions
- Malignancies, Cardiovascular Diseases, Children, Only
- Trial name
- NCT05602103
- Testing
- use of anticancer drugs in monotherapy or in combination therapy
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Caen
Vaccine Adverse Reaction
COVID-19 Vaccines Associated Malaise
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines…
- Trial name
- NCT05234333
- Testing
- SARS-CoV-2 vaccine
- Where
- France
- Volunteers
- 1,534,706 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Sepsis (SMQ), Opportunistic Infections
Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities
Although antibody-drug conjugate(ADC) has proved effective in treating many cancers, few patients receiving ADC may experience rare but life-threatening sepsis-related toxicities such as sepsis and septic shock.
- Conditions
- Sepsis (SMQ), Opportunistic Infections, Agranulocytosis
- Trial name
- NCT05349383
- Testing
- Antibody-Drug Conjugate, Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate
- Where
- China
- Volunteers
- 24,618 people
- Sponsor
- Central South University
Hunter Syndrome
Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
The purpose of this non-interventional, observational study which is conducted in Mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis II) being treated…
- Trial name
- NCT03582449
- Where
- 6 sites in Mexico
- Volunteers
- 5 people
- Sponsor
- Shire
Pulmonary Disease, Chronic Obstructive
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5.
- Trial name
- NCT00662805
- Testing
- Salmeterol/Fluticasone propionate
- Volunteers
- 762 people
- Sponsor
- GlaxoSmithKline
Oncology, Drugs
Active Pharmacovigilance of Anti-cancer Medicines
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims…
- Conditions
- Oncology, Drugs, Pharmacovigilance
- Trial name
- NCT05825794
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS Burlo Garofolo
Tuberculosis
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis.
- Trial name
- NCT04916899
- Testing
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Where
- Mexico
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
COVID-19 Vaccine Adverse Reaction
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.
- Trial name
- PEDIVACOV-HCSC (NCT06646744)
- Testing
- mRNA COVID-19 vaccine
- Where
- Spain
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Ana Belen Rivas Paterna
Malaria
Cohort Event Monitoring in Sub Saharan Africa
This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj.
- Trial name
- CEMISA (NCT02817919)
- Where
- 4 sites in Ghana
- Volunteers
- 1,126 people
- Sponsor
- African Collaborating Centre for Pharmacovigilance
Benign Prostatic Hyperplasia
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1).
- Trial name
- NCT00593593
- Volunteers
- 1,000 people
- Sponsor
- GlaxoSmithKline
Early Breast Cancer
Electronic Study for Anastrozole Pharmacovigilance Evaluation
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer
- Trial name
- E-SAFE (NCT00558168)
- Volunteers
- 1,850 people
- Sponsor
- AstraZeneca