HyperammonemiaAmmoTOXNCT03947034
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
An observational study of Hyperammonemia and Metabolic Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperammonemia, Metabolic Disease, Adverse Drug Event
- What is being tested?
- Drugs inducing hyperammonemia
- How many people
- 2,700 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Who may be able to join
- Case reported in the WHO's pharmacovigilance database till 01/05/2019
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, 75013
About this study
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).
Read the 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.
- Conditions
- Hyperammonemia, Metabolic Disease, Adverse Drug Event, Drug Toxicity
- Being tested
- Drugs inducing hyperammonemia
- Medical subject headings
- Hyperammonemia, Metabolic Diseases, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs inducing hyperammonemiaDrug
Drugs susceptible to induce metabolic toxicities such as hyperammonemia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Drugs inducing hyperammonemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: to 01/05/2019
Secondary outcomes (7)
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
Measured: to 01/05/2019
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
Measured: to 01/05/2019
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
Measured: to 01/05/2019
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
Measured: to 01/05/2019
Description of the drug-drug interactions associated with adverse events
Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: to 01/05/2019
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
Measured: to 01/05/2019
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
Measured: to 01/05/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 May 2019
- Primary completion30 May 2020
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperammonemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947034
- Sponsor's protocol ID
- CIC1421-19-09
- Acronym
- AmmoTOX
- Status last verified
- Apr 2023
- First submitted
- 9 May 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
- ClinicalTrials.gov ID
- NCT03947034
- Acronym / sponsor ID
- AmmoTOX / CIC1421-19-09
- Conditions
- Hyperammonemia, Metabolic Disease, Adverse Drug Event, Drug Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic toxicity induced by drugs and chemotherapies | – | Drug: Drugs inducing hyperammonemiaCase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Key inclusion criteria (1 listed)
- Case reported in the WHO's pharmacovigilance database till 01/05/2019
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drugs inducing hyperammonemiaDrugs susceptible to induce metabolic toxicities such as hyperammonemia | Drug | Metabolic toxicity induced by drugs and chemotherapies |
Primary outcome
Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.
Time frame: to 01/05/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
7 secondary outcomes
Causality assessment of reported metabolic toxicities events according to the WHO system
Time frame: to 01/05/2019
Description of the type of metabolic toxicity depending on the category of drug
Time frame: to 01/05/2019
Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs
Time frame: to 01/05/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: to 01/05/2019
Description of the drug-drug interactions associated with adverse events
Time frame: to 01/05/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: to 01/05/2019
Description of the population of patients having hematological toxicity adverse event
Time frame: to 01/05/2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperammonemia and Metabolic Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs. (time frame: to 01/05/2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.