An interventional study of exercise in Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
Among 15 studies in Hepatitis B, Chronic by National Taiwan University Hospital — 1 open to participants now, 2 under way, none of them phase 3. Hepatitis B, Chronic · National Taiwan University Hospital.
Among the 15 studies in Hepatitis B, Chronic by National Taiwan University Hospital, this one is the 10th largest by planned enrollment of the 13 interventional ones, is the only one that started in 2023, is one of 4 with no phase, and was the 15th registered.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →1 of the 15 studies in Hepatitis B, Chronic by National Taiwan University Hospital is open now, in 1 country. Each count lists the studies.
Of the 96 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 58 (60%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2023.
Median enrollment 160 across the 13 interventional studies, 112 across the 2 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
1 of the studies in Hepatitis B, Chronic by National Taiwan University Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05956379National Taiwan University HospitalChronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention. | 2027-07-31 |
Among the 15 studies in Hepatitis B, Chronic by National Taiwan University Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
The investigators will first collect and analyze clinical data of patients with concurrent MAFLD and HBV in a retrospective cohort in NTUH. The investigators aim to clarify the interactions of MAFLD and HBV based on different HBV-related liver disease stage and different metabolic derangement.
Second, using the well-established platform for the detection and staging of fatty liver at NTUH, the investigators plan to enroll 100 patients with concurrent HBV and MAFLD. The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and randomize them to the exercise intervention group (n = 50) and the observation group (n = 50) after conditional screening. After 6-month of exercise intervention, the investigators will analyze the effect of exercise on intrahepatic fat (main parameter: 10% reduction in intrahepatic fat; 30% achieved in the exercise intervention group; 5% achieved in the control group) and analyze the influence of co-existing HBV on the change of hepatic steatosis.
Description of the prospective randomized exercise intervention studies
II-1: Enrolment of subjects:
Patients from NTUH with the diagnosis of chronic HBV infection will be screened for the presence of MAFLD at the out-patient clinics. Treatment naïve patients found to have co-existing MAFLD and willing to join the active exercise program will be invited to join the study by the clinical physicians after thorough evaluation. Patients with age less than 18 years, concurrent HCV or HIV co-infection will be excluded.
CHB patients fulfilling reimbursement criteria for the treatment of HBAg-positive or -negative CHB, or advanced fibrosis/cirrhosis will not be enrolled since the virologic profiles under NUC therapy would not likely to be affected by the change of hepatic steatosis through exercise intervention.
Assessment of HBV replication status and liver disease severity: The clinical phenotype of HBV infection will be determined by liver function test (serum ALT level) and platelet count number, abdominal ultrasonography, FibroScan™, along with serum HBeAg and HBV DNA level. At enrolment, the patients will be categorized into HBeAg positive chronic HBV infection (immune tolerance phase), HBeAg positive chronic hepatitis B (immune clearance phase), HBeAg negative chronic HBV infection (low replication phase), and HBeAg negative chronic hepatitis B (reactivation phase). The stage of liver fibrosis will determined by FIB-4, FibroScan™and MR elastography (MRE).
Diagnosis and assessment of MAFLD: The diagnosis of MAFLD will be made if the patient has evidence of hepatic steatosis by both abdominal ultrasonography and FibroScan™, along with one of the three criteria, namely overweight/obesity, presence of type 2 diabetes mellitus (DM), and at least two metabolic risk abnormalities. Then the degree of hepatic steatosis and fibrosis will be semi-quantitatively assessed by FibroScan™. In this proposal, the investigators will for the first time adopt MR PDFF and MR elastography (MRE) to accurately assess the degree of steatosis and the stage of fibrosis in each enrolled subject before and after the intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physical therapists will provide personalized aerobic exercise program prescriptions in the preparatory period based on the results of exercise-related assessments, and the training intensity is based on the results of the maximum exercise test, with moderate intensity for 24 weeks, \>=3 cardio workouts per week.
Other: exercise
No change in exercise habits and maintaining baseline physical activity.
Physical therapists will provide personalized aerobic exercise program prescriptions in the preparatory period based on the results of exercise-related assessments, and the training intensity is based on the results of the maximum exercise test, with moderate intensity for 24 weeks, \>=3 cardio workouts per week. The form of aerobic exercise can be carried out in the form of treadmill walking, walking, jogging, cycling, aerobic dance, ball games, swimming, rope skipping, stepping exercises, etc. When the exercise reaches the target intensity, we will adjust the training intensity process according to personal ability. The physical therapist will again adjust the content of the aerobic exercise program at week 12 based on the reassessment of the exercise capacity.
Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
We will measure change of hepatic steatosis at week 24 in comparison to baseline steatosis by MRI-PDFF. Reduction of hepatic steatosis by \>=10% will be defined as responder.
Time frame: 24 weeks
Exploratory outcomes
1. Dynamics of HBV profiles after exercise 2. Impact of diminishing hepatic steatosis on the evolution of liver fibrosis 3. Impact of diminishing hepatic steatosis on the profiles of HBV replication
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2023; primary completion for Jul 2027, 47 months later.
Of 42 interventional studies with no phase under Hepatitis B, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 121. This study's planned 47 months is close to that.
How these figures are worked out, and which studies are left out of them.
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