The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.

NCT04886336 | Unknown

• 1 other identifier: B-ER 109-100
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HBV

Keywords

Body Weight; Metabolic; Tenofovir alafenamide

Outcome Measures

Primary Outcomes (1)

• 1.Body weight changes after shifting to TAF treatment.

  Collection Body weight data before and after treatment.

  48 weeks

Secondary Outcomes (4)

• 2.Changes of lipid and sugar profiles before and after shifting to TAF treatment.

  48 weeks.

• 3.Virologic responses following TAF treatment.

  48 weeks.

• 4.Renal function after shifting to TAF treatment.

  48 weeks.

• 5. ASCVD score changes before and after shifting to TAF treatment.

  48 weeks.

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We collection plasma.

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pin-Nan Cheng, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin-Nan Cheng, PhD

CONTACT

+886-972401223; pncheng@mail.ncku.edu.tw

Li-Chen Lin

CONTACT

+886-910819731; lichenlin516@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: June 4, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 14, 2021

Record last verified: 2020-07

Locations

TW (1)