Liver FibrosisHEPAGLYNCT07303140
Non-invasive Assessment of Liver Fibrosis in a French Cohort of Pediatric Patients With Type III Glycogen Storage Disease: Current State and Perspectives
An observational study of Liver Fibrosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with type III glycogen storage disease (GSDIII) can develop liver fibrosis, which can be complicated by liver failure or even hepatocellular carcinoma. Since the beginning of the 21st century, non-invasive techniques for assessing fibrosis, such as liver elastography, have been developed. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Liver Fibrosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 month to 21 years
- All sexes
- Child, Adult
Study population: Patients under 22 years of age
Who may be able to join
- Minors: from birth to 17 years
- Adults: 18 to 21 years
- Subjects being monitored for type III glycogen storage disease and having had at least one liver elastography measurement during their follow-up.
Who cannot join
- Patients monitored for type III glycogen storage disease but who had never undergone liver elastography during their follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Camille WICKER, MD, 33 3 88 12 77 12, camille.wicker@chru-strasbourg.fr
Camille WICKER, MD
About this study
Patients with type III glycogen storage disease (GSDIII) can develop liver fibrosis, which can be complicated by liver failure or even hepatocellular carcinoma. Since the beginning of the 21st century, non-invasive techniques for assessing fibrosis, such as liver elastography, have been developed. These techniques often make it possible to avoid liver biopsies during patient follow-up and have already been validated in the management of several diseases in adults. These techniques are also beginning to be recommended for monitoring certain chronic liver diseases in children.
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Type III glycogen storage disease, Liver fibrosis in pediatric patients
- Medical subject headings
- Liver Cirrhosis, Glycogen Storage Disease Type III
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver elastography values
Liver fibrosis is classified into four stages, from 0 to 4:
- F0 corresponds to the absence of fibrosis
- F4 corresponds to established cirrhosis.
Measured: 1 hour after consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start18 Oct 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303140
- Sponsor's protocol ID
- 9479
- Acronym
- HEPAGLY
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Liver Fibrosis in a French Cohort of Pediatric Patients With Type III Glycogen Storage Disease: Current State and Perspectives
- ClinicalTrials.gov ID
- NCT07303140
- Acronym / sponsor ID
- HEPAGLY / 9479
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Type III glycogen storage disease, Liver fibrosis in pediatric patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- 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.
Patients with type III glycogen storage disease (GSDIII) can develop liver fibrosis, which can be complicated by liver failure or even hepatocellular carcinoma. Since the beginning of the 21st century, non-invasive techniques for assessing fibrosis, such as liver elastography, have been developed. These techniques often make it possible to avoid liver biopsies during patient follow-up and have already been validated in the management of several diseases in adults. These techniques are also beginning to be recommended for monitoring certain chronic liver diseases in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients under 22 years of age
Key inclusion criteria (3 listed)
- Minors: from birth to 17 years
- Adults: 18 to 21 years
- Subjects being monitored for type III glycogen storage disease and having had at least one liver elastography measurement during their follow-up.
Key exclusion criteria (1 listed)
- Patients monitored for type III glycogen storage disease but who had never undergone liver elastography during their follow-up.
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
Liver elastography values
Time frame: 1 hour after consultation
Liver fibrosis is classified into four stages, from 0 to 4: * F0 corresponds to the absence of fibrosis * F4 corresponds to established cirrhosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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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.
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 Fibrosis, run by University Hospital, Strasbourg, France at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille WICKER, MD (33 3 88 12 77 12, camille.wicker@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver elastography values (time frame: 1 hour after consultation). It is what the study was designed to measure, not a finding.
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 Dec 2025.