Acetaminophen ToxicityNCT01005173
Acetaminophen Biomarkers
An observational study of Acetaminophen Toxicity, run by Arkansas Children's Hospital Research Institute at 8 sites in United States.
Trial summary
This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acetaminophen Toxicity
- How many people
- 253 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2009to Jun 2018
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children Ages 1-18 Group A - Hospitalized receiving acetaminophen Group B - Healthy volunteers - no acetaminophen within 14 days Group C - Acetaminophen Overdose - Hospitalized
Who may be able to join
- Group A:
- Children ages 1-18 inclusive
- Hospitalized children who are likely to receive or are receiving recommended doses of APAP
- Group B:
- Children ages 1-18 inclusive
- Children with no APAP use in the past 14 days
Show all 10Show fewer
- Group C:
- Children ages 1-18 inclusive
- Hospitalized from an acute overdose of APAP
- Time of APAP overdose is known or can be estimated within a two hour window
Who cannot join
- Group A:
- Acute or chronic APAP overdose within 14 days
- Known history of liver disease or dysfunction
- Group B:
- APAP within the last 14 days
- Known history of liver disease or dysfunction
Show all 10Show fewer
- Group C:
- Chronic overdoses of APAP, defined as multiple time point ingestions of APAP
- History of previous APAP overdose
- Known pre-existing liver disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Akron Children's Research Center
Akron, Ohio, 44308
Cook's Children's Health System
Fort Worth, Texas, 76104
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Kosair Charities Pediatric Clinical Research Unit University of Louisville
Louisville, Kentucky, 40202
University of Toledo Health Science Center
Toledo, Ohio
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen
This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of acetaminophen, and children and adolescents who are status post acetaminophen overdose. Ultimately, the data generated from this study will be used to establish second generation biomarkers of acetaminophen toxicity, based on specific adduct proteins, which can be used in future risk assessment studies of children receiving acetaminophen.
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen, APAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects | |
| Group B | Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects | |
| Group C | Acetaminophen Overdose Subjects - Hospitalized 90 Subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetaminophen ToxicityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Laura P James, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005173
- Sponsor's protocol ID
- 1R01DK081406-01A1
- Other IDs
- 1 R01 DK081406-01A1 - NIH
- Status last verified
- Nov 2017
- First submitted
- 28 Oct 2009
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen
- ClinicalTrials.gov ID
- NCT01005173
- Acronym / sponsor ID
- 1R01DK081406-01A1
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen, APAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2009
- Primary completion
- Jun 2018 (estimated)
- First posted
- 30 Oct 2009 (estimated)
- 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.
This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of acetaminophen, and children and adolescents who are status post acetaminophen overdose. Ultimately, the data generated from this study will be used to establish second generation biomarkers of acetaminophen toxicity, based on specific adduct proteins, which can be used in future risk assessment studies of children receiving acetaminophen.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects |
| Group B | – | –Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects |
| Group C | – | –Acetaminophen Overdose Subjects - Hospitalized 90 Subjects |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children Ages 1-18 Group A - Hospitalized receiving acetaminophen Group B - Healthy volunteers - no acetaminophen within 14 days Group C - Acetaminophen Overdose - Hospitalized
Key inclusion criteria (10 listed)
- Children ages 1-18 inclusive
- Hospitalized children who are likely to receive or are receiving recommended doses of APAP
- Children ages 1-18 inclusive
- Children with no APAP use in the past 14 days
- Children ages 1-18 inclusive
Key exclusion criteria (10 listed)
- Acute or chronic APAP overdose within 14 days
- Known history of liver disease or dysfunction
- APAP within the last 14 days
- Known history of liver disease or dysfunction
- Chronic overdoses of APAP, defined as multiple time point ingestions of APAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
Related trials for Acetaminophen Toxicity
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.
Laura P James, MD principal investigator
Arkansas Children's Hospital Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetaminophen Toxicity, run by Arkansas Children's Hospital Research Institute at 8 sites in United States.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Results are not available in the source record.
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.
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 24 Nov 2017.