Non-Alcoholic Fatty Liver DiseaseNCT03190538
Nonalcoholic Steatohepatitis in Chinese Children
An observational study of Non-Alcoholic Fatty Liver Disease, run by Humanity and Health Research Centre at 1 site in China.
Trial summary
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 May 2028
- 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 year to 18 years
- All sexes
- Child, Adult
Study population: Children with NAFLD who attended the Children's Liver Disease Center, 302 Hospital, Beijing, China will be identified and recruited. Participants met above inclusion and exclusion criteria will be invited to the study.
Who may be able to join
- age 1-18 with biopsy-proven NAFLD
- Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively
Who cannot join
- with viral hepatitis, e.g. HBV, HCV
- with a1-anti-trypsin disease
- with autoimmune hepatitis
- with Wilson disease
- with liver impaired by drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Liver Disease Center, 302 Hospital
Beijing
George Lau, MD, 852-28613777, gkklau@hnhmgl.com
Min Zhang, MD
About this study
Official title: Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.
A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- No intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no specific intervention to these paediatric NASH patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver related death
Whether the patients die from liver-related causes
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Complications of cirrhosis
Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up
Measured: Through study completion, an average of 1 year
Liver biopsy
Measured: Through study completion, an average of 2 year
Liver transplant
Whether the patients have liver transplant during the follow-up
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 May 2017
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Sponsor
- Investigators
- George Lau, MD, PhD, Principal investigator, Humanity and Health Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190538
- Sponsor's protocol ID
- H&H_ChildNASH_01
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2017
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
- ClinicalTrials.gov ID
- NCT03190538
- Acronym / sponsor ID
- H&H_ChildNASH_01
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Jun 2017 (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.
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.
A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with NAFLD who attended the Children's Liver Disease Center, 302 Hospital, Beijing, China will be identified and recruited. Participants met above inclusion and exclusion criteria will be invited to the study.
Key inclusion criteria (2 listed)
- age 1-18 with biopsy-proven NAFLD
- Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively
Key exclusion criteria (5 listed)
- with viral hepatitis, e.g. HBV, HCV
- with a1-anti-trypsin disease
- with autoimmune hepatitis
- with Wilson disease
- with liver impaired by drugs
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 |
|---|---|---|
| No interventionThere will be no specific intervention to these paediatric NASH patient | Other | – |
Primary outcome
Liver related death
Time frame: Through study completion, an average of 1 year
Whether the patients die from liver-related causes
3 secondary outcomes
Complications of cirrhosis
Time frame: Through study completion, an average of 1 year
Liver biopsy
Time frame: Through study completion, an average of 2 year
Liver transplant
Time frame: Through study completion, an average of 1 year
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 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Alcoholic Fatty Liver Disease
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
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.
George Lau, MD, PhD principal investigator
Humanity and Health Medical Centre
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 Non-Alcoholic Fatty Liver Disease, run by Humanity and Health Research Centre at 1 site in China.
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 2 inclusion and 5 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 29 Jul 2026. 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 China. 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 George Lau, MD, PhD (852-28613777, gkklau@hnhmgl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver related death (time frame: Through study completion, an average of 1 year). 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 29 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.