A comparative trial of metabolic parameters and cardiovascular risk in chronic hepatitis B patients who were treated with Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220209003

Enrollment

Registered

2022-02-09

Start date

2022-07-07

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B infection HBV

Interventions

Tenofovir alafenamide 25 mg/day orally ,Tenofovir disoproxil fumarate 300 mg/day orally

Experimental Drug,Active Comparator Drug

Tenofovir alafenamide,Tenofovir disoproxil fumarate

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Chronic HBV infection patient, age 40-75 yr. 2.Currently on TDF at least 1 yr and undetectable HBV viral load 3.Estimated GFR > 50 ml/min/1.73m 4.LDL cholesterol < 130 ml/dL more than 6 months or < 100 ml/dL in DM

Exclusion criteria

Exclusion criteria: 1.Co-infection with HCV or HIV 2.Patients who currently had other cancer or HCC 3.Patients who had cirrhosis or clinical liver decompensatiom 4.Previous organ transplantation 5.Previous diagnosed with stroke or coronary artery disease 6.Currently on immunosuppresive drugs 7.Patients whom plan to pregnant or current pregnant 8.Initial carotid doppler ultrasonography show carotid stenosis > 70% 9.Patients who had history of alcohol drinking > 2 standard drinks in male or > 1 standard drink in female

Design outcomes

Primary

Measure	Time frame
LDL cholesterol at 6,12 month after starting point of intervention mg/dL	—

Secondary

Measure	Time frame
BMI at 6,12 month after starting point of intervention kg/m2,Fasting blood sugar at 6,12 month after starting point of intervention mg/dL,Blood pressure at 6,12 month after starting point of intervention mmHg,Total cholesterol at 6,12 month after starting point of intervention mg/dL,HDL cholesterol at 6,12 month after starting point of intervention mg/dL,Triglyceride at 6,12 month after starting point of intervention mg/dL,risk ASCVD at 12 month after starting point of intervention ACC guideline,risk ASCVD at 12 month after starting point of intervention Thai CV risk score,ALT at 6,12 month after starting point of intervention U/L,Liver stiffness mesurement at 12 month after starting point of intervention CAP,Liver stiffness measurement at 12 month after starting point of intervention Transient elastography,Carotid atherosclerosis at 12 month after starting point of intervention CDUS intima media thickness,Muscle mass at 6,12 month after starting point of intervention BIA,Fat mass at 6,12 month after starting point of intervention BIA	—

Measure

Time frame

BMI at 6,12 month after starting point of intervention kg/m2,Fasting blood sugar at 6,12 month after starting point of intervention mg/dL,Blood pressure at 6,12 month after starting point of intervention mmHg,Total cholesterol at 6,12 month after starting point of intervention mg/dL,HDL cholesterol at 6,12 month after starting point of intervention mg/dL,Triglyceride at 6,12 month after starting point of intervention mg/dL,risk ASCVD at 12 month after starting point of intervention ACC guideline,risk ASCVD at 12 month after starting point of intervention Thai CV risk score,ALT at 6,12 month after starting point of intervention U/L,Liver stiffness mesurement at 12 month after starting point of intervention CAP,Liver stiffness measurement at 12 month after starting point of intervention Transient elastography,Carotid atherosclerosis at 12 month after starting point of intervention CDUS intima media thickness,Muscle mass at 6,12 month after starting point of intervention BIA,Fat mass at 6,12 month after starting point of intervention BIA

—

Countries

Thailand

Contacts

Public ContactWatcharasak Chotiyaputta

Siriraj hospital

Watcharagi@gmail.com024167282

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026