Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Metabolic Disease Clinical Trial

— AmmoTOX  

Official title:

Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947034
• Other study ID #: CIC1421-19-09
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: April 4, 2023
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Case reported in the WHO's pharmacovigilance database till 01/05/2019

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Hyperammonemia
• Metabolic Disease
• Metabolic Diseases

Intervention

Drug:
• Drugs inducing hyperammonemia
Drugs susceptible to induce metabolic toxicities such as hyperammonemia

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Causality assessment of reported metabolic toxicities events according to the WHO system	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the type of metabolic toxicity depending on the category of drug	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the duration of treatment when the toxicity happens (role of cumulative dose)	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019
Secondary	Description of the population of patients having hematological toxicity adverse event	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/05/2019