Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

• Sponsor: Groupe Hospitalier Pitie-Salpetriere (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03947034
• Collaborator: (none)
• Enrollment: 2,700
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 208.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Hyperammonemia; Metabolic Disease; Adverse Drug Event; Drug Toxicity	Drug: Drugs inducing hyperammonemia

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2700 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: May 30, 2020
• Anticipated Study Completion Date: May 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Drugs inducing hyperammonemia; Drugs susceptible to induce metabolic toxicities such as hyperammonemia

Outcome Measures

Primary Outcome Measures

1. Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs. [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary Outcome Measures

1. Causality assessment of reported metabolic toxicities events according to the WHO system [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

2. Description of the type of metabolic toxicity depending on the category of drug [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

3. Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

4. Description of the duration of treatment when the toxicity happens (role of cumulative dose) [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

5. Description of the drug-drug interactions associated with adverse events [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

6. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

7. Description of the population of patients having hematological toxicity adverse event [to 01/05/2019]

   Case reported in the World Health Organization (WHO) database of individual safety case reports

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris		France	75013

Sponsors and Collaborators

• Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere
• ClinicalTrials.gov Identifier: NCT03947034
• Other Study ID Numbers: CIC1421-19-09
• First Posted: May 13, 2019
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Metabolic Diseases; Hyperammonemia; Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of Sep 4, 2019