Liver DiseaseNCT00677625
Pediatric Liver Database
An observational study of Liver Disease and Liver Transplant, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Liver Disease, Liver Transplant
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to 15 Sep 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin
Who may be able to join
- Under 18 years of age
- newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated
- receive a liver transplant prior to their eighteenth birthday
Who cannot join
- Patients decline participation.
- Patients have no liver diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Pediatric Liver Disease and Liver Transplant Database
The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.
Read the detailed description
In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.
- Conditions
- Liver Disease, Liver Transplant
- Keywords
- Liver, Transplant
- Medical subject headings
- Liver Diseases
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 |
|---|---|---|
| Liver Disease (LD) | These child subjects have some form of liver disease (including those who need a liver transplant) or have already had a liver transplant. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJun 2003
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grzegorz Telega, Medical College of Wisconsin
- Investigators
- Grzegorz Telega, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677625
- Sponsor's protocol ID
- CHW 03/64 HRRC 188-03
- Status last verified
- Nov 2017
- First submitted
- 9 May 2008
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Liver Disease and Liver Transplant Database
- ClinicalTrials.gov ID
- NCT00677625
- Acronym / sponsor ID
- CHW 03/64 HRRC 188-03
- Conditions
- Liver Disease, Liver Transplant
- Keywords
- Liver, Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 14 May 2008 (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.
The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.
Detailed description
In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Disease (LD) | – | –These child subjects have some form of liver disease (including those who need a liver transplant) or have already had a liver transplant. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin
Key inclusion criteria (3 listed)
- Under 18 years of age
- newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated
- receive a liver transplant prior to their eighteenth birthday
Key exclusion criteria (2 listed)
- Patients decline participation.
- Patients have no liver diseases.
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
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 17 Nov 2017.
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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.
Grzegorz Telega, MD principal investigator
Medical College of Wisconsin
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 Liver Disease and Liver Transplant, run by Medical College of Wisconsin at 1 site 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 3 inclusion and 2 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 17 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 1 site 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?
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.
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 17 Nov 2017.