Clinical trials: Adverse Drug Event
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
Drug-Related Side Effects and Adverse Reactions
DOAC ADRs Retrospective Study
This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
- Trial name
- NCT04247919
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Cipherome, Inc.
Adverse Drug Event, Drug Drug Interaction
Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services.
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Trial name
- NCT04984538
- Testing
- Pharmacogenomic Testing
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
Osteoarthritis
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
- Trial name
- NCT02064634
- Where
- South Korea
- Volunteers
- 6,700 people
- Sponsor
- Green Cross Corporation
Migraine
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound.
- Trial name
- NCT04818515
- Testing
- Atogepant, Ubrogepant
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- AbbVie
Drug-Related Side Effects and Adverse Reactions, Treatment Failure
DOAC ADRs Retrospective Study on Genetic Variations
The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e.
- Trial name
- DARES1 (NCT04580589)
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Cipherome, Inc.
Nutritional and Metabolic Diseases
Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.
- Trial name
- NCT01367054
- Testing
- Metformin, Glifage
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Biocinese
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Observational Prospective Study OPTIMA II - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study.
- Trial name
- OPTIMAII (NCT02099565)
- Where
- Russia
- Volunteers
- 572 people
- Sponsor
- AstraZeneca
Juvenile Idiopathic Arthritis
Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin".
- Trial name
- SELECT-sJIA (NCT05609630)
- Testing
- Upadacitinib, Tocilizumab
- Where
- 45 sites in United States, Argentina and 15 more
- Volunteers
- 90 people
- Sponsor
- AbbVie
Multiple Myeloma
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in…
- Trial name
- NCT06896916
- Testing
- Etentamig, Iberdomide
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 135 people
- Sponsor
- AbbVie
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare
Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung.
- Conditions
- Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer
- Trial name
- NCT05005403
- Testing
- Azirkitug, Budigalimab, Bevacizumab
- Where
- 48 sites in United States, Canada and 4 more
- Volunteers
- 694 people
- Sponsor
- AbbVie
COVID, Drug Effect
Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications
This retrospective cohort study will include eligible patients that received a positive COVID-19 test and filled a new prescription for one of the repurposed medications (including hydroxychloroquine, chloroquine, with or without…
- Conditions
- COVID, Drug Effect, Drug Interaction, Risk Reduction
- Trial name
- NCT04432350
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
Juvenile Psoriatic Arthritis
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.
- Trial name
- NCT06100744
- Testing
- Adalimumab, Risankizumab
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 40 people
- Sponsor
- AbbVie
Advanced Solid Tumor, Tumor Associated Lymph Node T Cell
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination…
- Conditions
- Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, Immunotherapy
- Trial name
- TAL-T (NCT06302062)
- Testing
- Tumor Associated Lymph node T cell, cyclophosphamide, IL-2
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Healthy Volunteer Study
Safety Study of CZ10 in Healthy Volunteers
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast…
- Trial name
- NCT06708767
- Testing
- Contrast Media
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nextrast, Inc.
Genetics of Drug Metabolism
Utility of PharmacoGenomics for Reducing Adverse Drug Effects
UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency…
- Trial name
- UPGRADE (NCT02081872)
- Where
- 41 sites in United States
- Volunteers
- 279,000 people
- Sponsor
- Companion Dx Reference Lab, LLC
Genetics of Drug Metabolism
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on…
- Trial name
- POETRY (NCT02095769)
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 280,000 people
- Sponsor
- General Genetics Corporation
Coronary Artery Disease, Clopidogrel Resistance
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug…
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events
- Trial name
- NCT06665919
- Testing
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
- Where
- 4 sites in Georgia
- Volunteers
- 283 people
- Sponsor
- Vistamedi Ltd.
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation