HBVHBVNCT04886336
The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.
An observational study of HBV, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy. In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HBV
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jun 2020to 31 Dec 2022
- How long will I take part?
- 48 Weeks
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic hepatitis B patients who have been treated with TDF (n=100) or entecavir (n=100) will switch to TAF. In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, patient's decision, and physician's judgement according to clinical conditions. The scheduled treatment duration from enrolment should be greater than one year. Treatment indications for HBeAg-positive chronic hepatitis B, HBeAg-negative chronic hepatitis B and liver cirrhosis are based on reimbursement criteria of Taiwan government.
Who may be able to join
- Age more than 20 years.
- Chronic hepatitis B virus infection defined as presence of positive HBsAg more than 6 months.
- TAF naïve.
- Patients already receiving TDF or entecavir treatment, and the scheduled NUC treatment from enrolment being greater than one year.
Who cannot join
- Other etiology of chronic hepatitis.
- Severe comorbid disorders.
- Patients with History of acute coronary syndrome, myocardial infarction, stable angina, coronary/other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease from atherosclerosis.
- Uncontrolled diabetes mellitus (HBA1c > 8.5%).
- Current evidence or suspicious of malignancy.
- eGFR <50 ml/min/1.73m2.
- Any one of following hematology or biochemical or clinical abnormalities indicating the presence of liver decompensation: Albumin <3.5g/dL, Total Bilirubin >2.5mg/dL, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.
- Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Pin-Nan Cheng, PhD, +886-972401223, pncheng@mail.ncku.edu.tw
Li-Chen Lin, +886-910819731, lichenlin516@gmail.com
About this study
Official title: The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients
The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy.
In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically.
Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.
Read the detailed description
Currently, three oral nucleoside/tides analogues (NUC), including entecavir(ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), are available as the first line of treatment option for chronic hepatitis B (CHB) in Taiwan. Among them, TDF exhibits a greater decline of cholesterol, High-density lipoprotein(HDL), and low-density lipoprotein (LDL) levels than entecavir, while the impact of such general lipid-lowering effects on the risk of atherosclerotic cardiovascular diseases (ASCVD) remains unclear. For metabolic features, the evidence comes from HIV patients treated with TDF or TAF containing anti-retroviral therapy (ART). In one study revealed that a 0.45 kg/m2 increase of body mass index (BMI) and a 13% of increase in ASCVD risk score after switching from TDF-containing to TAF-containing ART. Weight gain after starting ART has been reported to associate with lower mortality in initial under-weight or normal-weight HIV patients. However, a study compared the efficacy and safety of dolutegravir/TAF/emtricitabine, dolutegravir/TDF/emtricitabine, and EFV/TDF/emtricitabine and revealed that patients receiving TAF and TDF containing regimens significantly increased body weight. The subsequent body composition analysis showed weight gain mainly resulted from increased lean muscle and fat of trunk and limb. A previous study also showed that the ART-associated increase in muscle area, regardless of regimen, is likely a reflection of increased fat within the muscle that may associate with weakness of muscle strength, risk of fall, and a decline of physical activities.
Overall, in HIV-infected patients, TAF-containing regimens had been shown to increase body weight resulting from increased fat and muscle of trunk and limb. However, it remains unknown whether all these findings in HIV infected patients could be similarly observed in CHB patient receiving TAF therapy, which is commonly encountered in Asia-Pacific region. Moreover, the mechanisms underlying these changes are still unclear. The long-term clinical impact of the BW gain and associated metabolic derangement is also unknown.
- Conditions
- HBV
- Keywords
- Body Weight, Metabolic, Tenofovir alafenamide
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir Disoproxil Fumarate(TDF) switch to TAF | The indications of TDF switching to TAF due to adverse events of TDF or physician's judgement according to clinical conditions. | |
| Entecavir(ETV)switch to Tenofovir Alafenamide(TAF) | In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, physician's judgement according to clinical conditions. | |
| observation groups with take either entecavir (25patients) or TDF (25 patients). | observation groups with total 50 patients who continuously take either entecavir (25patients) or TDF (25 patients) will be enrolled.Examination schedules for these two additional groups are the same as switching groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Body weight changes after shifting to TAF treatment.
Collection Body weight data before and after treatment.
Measured: 48 weeks
Secondary outcomes (4)
2.Changes of lipid and sugar profiles before and after shifting to TAF treatment.
Collection lipid( include TG<mg/dl>/Chol<mg/dl>,/LDL<mg/dl>/ HDL<mg/dl>) data and sugar profiles(include Insulin<uU/ml>, fasting sugar<mg/dl>, glycosylated hemoglobin<%>) data before and after treatment.
Measured: 48 weeks.
3.Virologic responses following TAF treatment.
Collection Virologic data (e.g HBV DNA<IU/ml>,)before and after treatment.
Measured: 48 weeks.
4.Renal function after shifting to TAF treatment.
Collection Renal function(include Cr<mg/dL>/eGFR<ml/min/1.73m2>)data before and after treatment.
Measured: 48 weeks.
5. ASCVD score changes before and after shifting to TAF treatment.
Collection ASCVD score before and after treatment.
Measured: 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start4 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin-Nan Cheng, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886336
- Sponsor's protocol ID
- B-ER 109-100
- Acronym
- HBV
- Status last verified
- Jul 2020
- First submitted
- 5 May 2021
- Last updated
- 14 May 2021
- 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 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT04886336
- Acronym / sponsor ID
- HBV / B-ER 109-100
- Conditions
- HBV
- Keywords
- Body Weight, Metabolic, Tenofovir alafenamide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 May 2021 (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.
The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy.
In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically.
Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.
Detailed description
Currently, three oral nucleoside/tides analogues (NUC), including entecavir(ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), are available as the first line of treatment option for chronic hepatitis B (CHB) in Taiwan. Among them, TDF exhibits a greater decline of cholesterol, High-density lipoprotein(HDL), and low-density lipoprotein (LDL) levels than entecavir, while the impact of such general lipid-lowering effects on the risk of atherosclerotic cardiovascular diseases (ASCVD) remains unclear. For metabolic features, the evidence comes from HIV patients treated with TDF or TAF containing anti-retroviral therapy (ART). In one study revealed that a 0.45 kg/m2 increase of body mass index (BMI) and a 13% of increase in ASCVD risk score after switching from TDF-containing to TAF-containing ART. Weight gain after starting ART has been reported to associate with lower mortality in initial under-weight or normal-weight HIV patients. However, a study compared the efficacy and safety of dolutegravir/TAF/emtricitabine, dolutegravir/TDF/emtricitabine, and EFV/TDF/emtricitabine and revealed that patients receiving TAF and TDF containing regimens significantly increased body weight. The subsequent body composition analysis showed weight gain mainly resulted from increased lean muscle and fat of trunk and limb. A previous study also showed that the ART-associated increase in muscle area, regardless of regimen, is likely a reflection of increased fat within the muscle that may associate with weakness of muscle strength, risk of fall, and a decline of physical activities.
Overall, in HIV-infected patients, TAF-containing regimens had been shown to increase body weight resulting from increased fat and muscle of trunk and limb. However, it remains unknown whether all these findings in HIV infected patients could be similarly observed in CHB patient receiving TAF therapy, which is commonly encountered in Asia-Pacific region. Moreover, the mechanisms underlying these changes are still unclear. The long-term clinical impact of the BW gain and associated metabolic derangement is also unknown.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 48 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir Disoproxil Fumarate(TDF) switch to TAF | – | –The indications of TDF switching to TAF due to adverse events of TDF or physician's judgement according to clinical conditions. |
| Entecavir(ETV)switch to Tenofovir Alafenamide(TAF) | – | –In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, physician's judgement according to clinical conditions. |
| observation groups with take either entecavir (25patients) or TDF (25 patients). | – | –observation groups with total 50 patients who continuously take either entecavir (25patients) or TDF (25 patients) will be enrolled.Examination schedules for these two additional groups are the same as switching groups. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients who have been treated with TDF (n=100) or entecavir (n=100) will switch to TAF. In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, patient's decision, and physician's judgement according to clinical conditions. The scheduled treatment duration from enrolment should be greater than one year. Treatment indications for HBeAg-positive chronic hepatitis B, HBeAg-negative chronic hepatitis B and liver cirrhosis are based on reimbursement criteria of Taiwan government.
Key inclusion criteria (4 listed)
- Age more than 20 years.
- Chronic hepatitis B virus infection defined as presence of positive HBsAg more than 6 months.
- TAF naïve.
- Patients already receiving TDF or entecavir treatment, and the scheduled NUC treatment from enrolment being greater than one year.
Key exclusion criteria (8 listed)
- Other etiology of chronic hepatitis.
- Severe comorbid disorders.
- Patients with History of acute coronary syndrome, myocardial infarction, stable angina, coronary/other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease from atherosclerosis.
- Uncontrolled diabetes mellitus (HBA1c > 8.5%).
- Current evidence or suspicious of malignancy.
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
1.Body weight changes after shifting to TAF treatment.
Time frame: 48 weeks
Collection Body weight data before and after treatment.
4 secondary outcomes
2.Changes of lipid and sugar profiles before and after shifting to TAF treatment.
Time frame: 48 weeks.
3.Virologic responses following TAF treatment.
Time frame: 48 weeks.
4.Renal function after shifting to TAF treatment.
Time frame: 48 weeks.
5. ASCVD score changes before and after shifting to TAF treatment.
Time frame: 48 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Related trials for HBV
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Pin-Nan Cheng, PhD principal investigator
National Cheng-Kung University Hospital
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 HBV, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 May 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pin-Nan Cheng, PhD (+886-972401223, pncheng@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Body weight changes after shifting to TAF treatment. (time frame: 48 weeks). 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 14 May 2021.