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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1080222765 | Registry Identifier | jRCT |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fomepizole Intravenous Infusion | Fomepizole Intravenous Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fomepizole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
| 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. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
| 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. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
| 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. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
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Inclusion Criteria:
-All patients who have been confirmed as receiving the drug
Exclusion Criteria:
-None
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Ethylene glycol poisoning or methanol poisoning
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Sponsored Site | Osaka | Japan | ||||
| Takeda Sponsored Site |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of ethylene glycol and methanol poisonings were enrolled. Participants received fomepizole as part of a routine medical care.
Participants took part in the survey at 91 investigative sites in Japan, from 27 January 2015 to 30 June 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number analyzed is the number of participants with data available for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
|
From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2022 | Jun 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2022 | Jun 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077604 | Fomepizole |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. | Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) |
| Tokyo |
| Japan |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
|
| Alcohol Consumption (at Time of Poisoning) | Number of participants who had been consuming alcohol at the time of poisoning was reported. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Pregnancy Status | This baseline characteristic was analyzed only in female participants. Unknown: Data could not be collected. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
|
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| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
|
|
|
| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
|
|
|
| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | pH | Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) |
|
|
|
| 7 |
| 131 |
| 13 |
| 131 |
| 3 |
| 131 |
| Cerebral haemorrhage | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Putamen haemorrhage | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Death | General disorders | MedDRA/J v25.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA/J v25.0 | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
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| 24 Hours after the Last Dose |
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