NCT03471624

Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

Completed Phase 4 Results posted Last updated 18 November 2023

What this trial tests

Phase 4 trial testing Tenofovir Alafenamide in Hepatitis B, Chronic in 270 participants. Completed in 19 April 2022.

Timeline

1 May 2018

Primary endpoint
19 April 2022

19 April 2022

Quick facts

Lead sponsor	Stanford University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	270
Start date	1 May 2018
Primary completion	19 April 2022
Estimated completion	19 April 2022
Sites	12 locations across Taiwan, Japan, United States, South Korea

Drugs / interventions tested

• Tenofovir Alafenamide (TENOFOVIR ALAFENAMIDE) — full drug profile →

Conditions studied

• Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With HBV DNA <20 IU Per mL Primary · Baseline, 6, 12, 18, 24 months

To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment.

Baseline

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	257

month 6

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	261

month 12

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	257

month 18

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	256

month 24

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	255

Number of Participants With Normal Alanine Aminotransferase (ALT). Secondary · Baseline, 6, 12, 18, 24 months

Alanine aminotransferase (ALT) normalization is defined if ALT was less than 35 U/L for men or 25 U/L for women

Baseline

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	203

month 6

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	212

month 12

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	197

month 18

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	203

month 24

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	203

Calculated eGFR Secondary · Baseline, 6, 12, 18, 24 months

To describe trends in calculated eGFR as available by local labs. Estimated glomerular filtration rates (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equation (eGFR \[mL∕min∕1.73m2\] =141 × \[minimum Scr∕K, 1\]α × \[maximum Scr/K, 1\]1.209 × 0.993age × 1.018 \[if female\] × 1.159 \[if black\]) where Scr is serum creatinine in µmol/L, K is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males

Baseline

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	90.2	79.0 – 99.8

month 6

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	90.8	76.9 – 100

month 12

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	91.2	78 – 101.1

month 18

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	91.8	79.9 – 101.7

month 24

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	92.1	78.8 – 101.0

The Mean Bone Mass Density (T-score) Change Secondary · Baseline, month 24

To describe trends in bone mass density from baseline to end of study. Bone Mass Density(BMD) was evaluated using T-score of Lumber-spine. The T-score is a comparison of the results to a average peak bone mass of healthy young adult. 0 indicates healthy young adult's mean with a SD of 1. Normal BMD was defined with T-score of -1.0 or above; osteopenia with T-score between -1.1 and -2.4, and osteoporosis with T-score of -2.5 or below (ref). Worsened BMD was defined by upstaging of BMD class from normal to osteopenia or worse or from osteopenia to osteoporosis. Improved BMD was defined by downst

Baseline

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	-1.43	± 1.36

24 month

Group	Value	95% CI
Tenofovir Alafenamide for 24 Months	-1.17	± 1.38

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tenofovir Alafenamide for 24 Months

Serious: 15/270 (6%)

Deaths: 1/270

Serious adverse events (12 terms)

Reaction	System	Tenofovir Alafenamide for …
Hepatocellular carcinoma	Hepatobiliary disorders	—
Gallbladder carcinoma	Hepatobiliary disorders	—
Non-Hodgkin's Lymphoma	Blood and lymphatic system disorders	—
Skin T cell Lymphoma	Skin and subcutaneous tissue disorders	—
Prostate cancer	Reproductive system and breast disorders	—
Breast cancer	Reproductive system and breast disorders	—
Rectal adenocarcinoma	Gastrointestinal disorders	—
Myelodysplastic syndrome	Blood and lymphatic system disorders	—
Angina pectoris	Cardiac disorders	—
Brain hemorrhage	Nervous system disorders	—
Hemorrhoids	Gastrointestinal disorders	—
Left Knee osteoarthritis	Musculoskeletal and connective tissue disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Tenofovir Alafenamide for …
Nausea	Gastrointestinal disorders	—
Body pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Hepatocellular carcinoma, Gallbladder carcinoma, Non-Hodgkin's Lymphoma, Skin T cell Lymphoma, Prostate cancer, Breast cancer, Rectal adenocarcinoma, Myelodysplastic syndrome.

Data from ClinicalTrials.gov NCT03471624 adverse events section.

Sponsor's own description

Primary Objective:

To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.