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NCT05956379Enrolling by invitation

Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.

Source: ClinicalTrials.gov · Last updated 21 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

In Taiwan, HBV infection is endemic in the adult population. With the westernization of eating habit and lifestyle, metabolic syndrome and related non-alcoholic fatty liver diseases (NAFLD, newly proposed as metabolic dysfunction associated fatty liver diseases, MAFLD) has become another important health issue. It is therefore common to encounter subjects with concurrent MAFLD and HBV infection in HBV endemic countries. This project will study the clinical data of patients with concurrent MAFLD and HBV, and aim to explore the impact of exercise intervention on the hepatic fatty infiltration, alteration of gut microbiota and HBV replication status in this group of patients. The research strategies will include (1) improving fatty liver and metabolic syndrome in subjects with concurrent MAFLD and HBV; and (2) exploring the changes of HBV replication and intestinal microflora in patients with concurrent HBV and MAFLD after exercise intervention.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
100 (estimated)
First submitted
13 Jun 2023
Start date
1 Aug 2023
Primary completion date
31 Jul 2027
Lead sponsor
National Taiwan University Hospital
NCT number
NCT05956379

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Aug 2023 to the primary completion date, 31 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients fulfilling reimbursement criteria for HBV treatment
  • Evidence of severe cardiopulmonary diseases
  • Clinical diagnosis of Alzheimer's Disease
  • Thyroid disease

Lab values

  • Evidence of active HCV (positive for serum HCV RNA) or HIV infection (positive for anti-HCV)

Age

  • Age \>70 years of age

Other

  • Evidence of liver cirrhosis
  • Evidence of serious hip or knee problems, incapable of taking exercise
  • Evidence of liver decompensation

Who the study is looking for

  • Age \>18 years of age
  • Either gender
  • HBV treatment naïve
  • Capable of taking exercise
  • HBsAg positivity for \>6 months
  • Evidence of fatty liver in both abdominal ultrasonography and Fibroscan™(CAP\>215)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.