CholestasisCHOLESTASENCT02767648

Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

An observational study of Cholestasis, run by University Hospital, Toulouse at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis. Read more about this study

Who is it for?: Ages Up to 1 year
Conditions the study is for: Cholestasis
What is being tested?: proteomic urine analysis
How many people: 57 participants
Where: 4 sitesFrance
Study dates: May 2010to Oct 2013
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 1 year
All sexes
No healthy volunteers
Child

Study population: infant suffering from cholestasis

Who may be able to join

Infant <1 year suffering from cholestasis

Who cannot join

Rejection or inability for parent to give their informed consent

Trial locations and contacts

4 sites in 1 country.

France4 sites

UH Bordeaux
Bordeaux
UH Limoges
Limoges
UH Montpellier
Montpellier, 34000
UH Toulouse
Toulouse, 31000

Other trials in France

About this study

The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

Conditions: Cholestasis
Being tested: proteomic urine analysis
Keywords: cholestasis, neonatal, infant
Medical subject headings: Cholestasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

proteomic urine analysisOther
proteomic urine analysis

Study groups in NCT02767648
Study group	Role	What they receive
cholestasis		infant suffering from cholestasis proteomic urine analysis Receives: Other: proteomic urine analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies
Measured: Day 1 (inclusion)
Gathering new born epidemiologic characteristics as assessed by birth informations collection
Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care
Measured: Day 1 (inclusion)
Epidemiologic characteristics follow up as assessed by medical monitoring
Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death
Measured: When children are between 12 and 18 months old

Secondary outcomes (3)

Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte
Homogenize the care pathway of neonatal and infant cholestasis
Measured: Up to 3 years
Extend the study to the national french territory using the hepatology association network
Use this study to start a national study
Measured: Up to 3 years
Identification of proteomic profiles using the biologic collection gathered in the cohorte population
Identify one or more specific proteomic profile of neonatal cholestasis
Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Oct 2013

First posted10 May 2016 (estimated)
Study startMay 2010
Primary completionOct 2013
Study completionOct 2013

Why it stopped: recruitment difficulties

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CholestasisStudies of the same condition, open and under way.
More trials run by University Hospital, ToulouseThe 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02767648
Sponsor's protocol ID: 08 030 08
Other IDs: 2008
Acronym: CHOLESTASE
Status last verified: May 2016
First submitted: 10 Jul 2015
Last updated: 10 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Progressive Familial Intrahepatic Cholestasis
Active, not recruitingObservational study
Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
PFIC - Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
Progressive Familial Intrahepatic Cholestasis
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis

All Cholestasis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
ClinicalTrials.gov ID: NCT02767648
Acronym / sponsor ID: CHOLESTASE / 08 030 08
Conditions: Cholestasis
Keywords: cholestasis, neonatal, infant
Study type: Observational
Recruitment status: TerminatedReason stopped: recruitment difficulties
Enrolment: 57 participants (actual)
Lead sponsor: University Hospital, ToulouseUniversity, hospital or other
Study start: May 2010
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 10 May 2016 (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 goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
cholestasis	–	Other: proteomic urine analysisinfant suffering from cholestasis proteomic urine analysis

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: infant suffering from cholestasis

Key inclusion criteria (1 listed)

Infant <1 year suffering from cholestasis

Key exclusion criteria (1 listed)

Rejection or inability for parent to give their informed consent

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
proteomic urine analysisproteomic urine analysis	Other	cholestasis

Primary outcome

Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
Time frame: Day 1 (inclusion)
Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies
Gathering new born epidemiologic characteristics as assessed by birth informations collection
Time frame: Day 1 (inclusion)
Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care
Epidemiologic characteristics follow up as assessed by medical monitoring
Time frame: When children are between 12 and 18 months old
Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death

3 secondary outcomes

Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte
Time frame: Up to 3 years
Extend the study to the national french territory using the hepatology association network
Time frame: Up to 3 years
Identification of proteomic profiles using the biologic collection gathered in the cohorte population
Time frame: Up to 3 years

Results and safety

The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.

Related trials for Cholestasis

RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Progressive Familial Intrahepatic Cholestasis
Active, not recruitingObservational study
Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
PFIC - Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
Progressive Familial Intrahepatic Cholestasis
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis

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.

Pierre Broue, MD principal investigator

UH Toulouse

Thierry Lamireau, MD principal investigator

University Hospital, Bordeaux

Jane Languepin, MD principal investigator

UH Limoges

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cholestasis, run by University Hospital, Toulouse at 4 sites 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: stopped early, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 was stopped early (reason given: recruitment difficulties). 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.

What does the primary outcome measure?

Gathering mother epidemiologic characteristics as assessed by pregancy informations collection (time frame: Day 1 (inclusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767648.

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 10 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.