Ethylene Glycol Poisoning, Methanol Poisoning
Conditions
Keywords
Pharmacotherapy
Brief summary
The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.
Detailed description
Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required. This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g Takeda, hereinafter referred to as the drug) was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.
Interventions
DRUGFomepizole
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-All patients who have been confirmed as receiving the drug
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Events (AEs) | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Number of Participants Who Had One or More Adverse Drug Reactions | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants Reporting One or More Serious Adverse Events (SAEs) | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Number of Participants Who Had One or More Serious Adverse Drug Reactions | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug. |
| Arterial Blood pH | Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) | pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 91 investigative sites in Japan, from 27 January 2015 to 30 June 2022.
Pre-assignment details
Participants with a historical diagnosis of ethylene glycol and methanol poisonings were enrolled. Participants received fomepizole as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Fomepizole Intravenous Infusion The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 16 |
Baseline characteristics
| Characteristic | Fomepizole Intravenous Infusion | — |
|---|---|---|
| Age, Continuous | 43.6 Years STANDARD_DEVIATION 20.65 | — |
| Alcohol Consumption (at Time of Poisoning) No | 80 Participants | — |
| Alcohol Consumption (at Time of Poisoning) Unknown | 24 Participants | — |
| Alcohol Consumption (at Time of Poisoning) Yes | 27 Participants | — |
| BMI | 22.71 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.78 | — |
| Height | 162.9 Centimeters (cm) STANDARD_DEVIATION 14.01 | — |
| Medical Complications Had Medical Complications | 78 Participants | — |
| Medical Complications Had No Medical Complications | 52 Participants | — |
| Medical Complications Unknown | 1 Participants | — |
| Medical History Had Medical History | 33 Participants | — |
| Medical History Had No Medical History | 94 Participants | — |
| Medical History Unknown | 4 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 108 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 11 Participants | — |
| Predisposition to Hypersensitivity Unknown | 12 Participants | — |
| Pregnancy Status Not Pregnant | 42 Participants | — |
| Pregnancy Status Pregnant | 0 Participants | — |
| Pregnancy Status Unknown | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 131 Participants | — |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 87 Participants | — |
| Weight | 60.99 Kilograms (kg) STANDARD_DEVIATION 16.752 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 131 |
| other Total, other adverse events | 3 / 131 |
| serious Total, serious adverse events | 13 / 131 |
Outcome results
Primary
Arterial Blood pH
pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported.
Time frame: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)
Population: Participants in the Efficacy Analysis Set for whom test value/s from at least one assessment time point is/are available from both before and after the start of fomepizole intravenous infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fomepizole Intravenous Infusion | Arterial Blood pH | Baseline | 7.3010 pH | Standard Deviation 0.16064 |
| Fomepizole Intravenous Infusion | Arterial Blood pH | 4 Hours after the First Dose | 7.4042 pH | Standard Deviation 0.06809 |
| Fomepizole Intravenous Infusion | Arterial Blood pH | 24 Hours after the Last Dose | 7.4120 pH | Standard Deviation 0.05078 |
Primary
Number of Participants Reporting One or More Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fomepizole Intravenous Infusion | Number of Participants Reporting One or More Adverse Events (AEs) | 22 Participants |
Primary
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fomepizole Intravenous Infusion | Number of Participants Reporting One or More Serious Adverse Events (SAEs) | 13 Participants |
Primary
Number of Participants Who Had One or More Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fomepizole Intravenous Infusion | Number of Participants Who Had One or More Adverse Drug Reactions | 7 Participants |
Primary
Number of Participants Who Had One or More Serious Adverse Drug Reactions
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fomepizole Intravenous Infusion | Number of Participants Who Had One or More Serious Adverse Drug Reactions | 0 Participants |