Clinical trials: Pharmacovigilance
Serious Adverse Events, Patient Safety
Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.
- Conditions
- Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
- Trial name
- NCT07592234
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- St Vincent's University Hospital, Ireland
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
Cancer
Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)
Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL).
- Trial name
- NCT06251648
- Testing
- Lenalidomide
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Caen
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
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
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
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
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
Adverse Drug Reaction
Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the…
- Trial name
- EIPhv (NCT02134587)
- Testing
- Multifaceted educational intervention
- Where
- Brazil
- Volunteers
- 203 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Car T- Cell, Hematologic Malignancy
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.
- Conditions
- Car T- Cell, Hematologic Malignancy, Acute Lymphoblastic Leukemia, Lymphoma, B-Cell
- Trial name
- Cardio CAR-T (NCT06350994)
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Safety Issues
Direct Acting Anti-Viral's In Chronic HCV Patients
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated…
- Trial name
- NCT04664894
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 511 people
- Sponsor
- Getz Pharma
Hypertension
Pharmacovigilance and Patient Compliance in Hypertensive Patients
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan.
- Trial name
- NCT02200575
- Testing
- Telmisartan
- Volunteers
- 10,333 people
- Sponsor
- Boehringer Ingelheim
Inflammatory Disease, Drug Side Effect
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic…
- Conditions
- Inflammatory Disease, Drug Side Effect, Drug Use, Adverse Drug Event
- Trial name
- LOOK-UP (NCT06498167)
- Testing
- Upadacitinib
- Where
- 3 sites in Portugal
- Volunteers
- 150 people
- Sponsor
- Universidade do Porto
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
Arrhythmias, Cardiac, Atrial Fibrillation and Flutter
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study
Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation and Flutter, Tachycardia, Supraventricular, Cardiac Failure
- Trial name
- ARBITRAGE (NCT03243604)
- Testing
- L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)
- Where
- France
- Volunteers
- 1,717 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Dementia, Depression
Pharmacovigilance in Gerontopsychiatric Patients
The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients.
- Conditions
- Dementia, Depression, Schizophrenia, Psychosomatic Disorders
- Trial name
- GAP (NCT02374567)
- Testing
- Phenobarbital, Phenytoin, Carbamazepine
- Where
- 5 sites in Germany
- Volunteers
- 407 people
- Sponsor
- Hannover Medical School
Heparin-induced Thrombocytopenia
Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52…
- Trial name
- Score-TIH (NCT00748839)
- Where
- 27 sites in France
- Volunteers
- 2,700 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Prostate Cancer, Neuropathy
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
- Conditions
- Prostate Cancer, Neuropathy, Epilepsy, Encephalopathy
- Trial name
- VENDY (NCT04290611)
- Testing
- Enzalutamide
- Where
- France
- Volunteers
- 500,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Melanoma
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period
- Trial name
- NCT02050594
- Testing
- Ipilimumab
- Where
- Venezuela
- Volunteers
- 6 people
- Sponsor
- Bristol-Myers Squibb