Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.

NCT03091556

Drug-Induced Liver Injury

UNKNOWN

Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment

NCT02170220

Severe Hepatic Impairment

COMPLETED PHASE1

Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function

NCT00698464

Hepatic Cirrhosis Alcoholism

COMPLETED PHASE1

Identification of PAthways of Kinase Inhibitors TOxicity

NCT03896139

Kinase Inhibitors Toxicity

COMPLETED

Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)

NCT01004770

Healthy

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperammonemia Metabolic Disease Adverse Drug Event Drug Toxicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metabolic toxicity induced by drugs and chemotherapies

Case reported in the World Health Organization (WHO) of metabolic toxicities(such as hyperammonemia) of patient treated by a drug, with a chronology compatible with the drug toxicity