Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
CompletedPhase 4Results postedLast updated 14 February 2022
What this trial tests
Phase 4 trial testing Tenofovir disoproxil fumarate in Hepatitis B, Chronic in 197 participants. Completed in 4 December 2020.
Adults 18 to 60, 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.
Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240Primary· Week 240
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of t
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
6.045
Percentage of Participants With Disease Progression at Week 240Primary· Week 240
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
7.2
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192Secondary· Week 48, Week 96, Week 144 and Week 192
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of t
Week 48
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
Week 96
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
Week 144
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
4
Week 192
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
9
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240Secondary· Week 48, Week 96, Week 144, Week 192 and Week 240
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of t
Week 48
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
NA – NA
Week 96
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
NA – NA
Week 144
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
2.1
0.0 – 4.3
Week 192
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
4.6
1.4 – 7.8
Week 240
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
5.6
2.1 – 9.1
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240Secondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with
Week 48
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
2.1
0.0 – 4.3
Week 96
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
2.6
0.1 – 5.0
Week 144
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
4.1
1.1 – 7.1
Week 192
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
7.2
3.3 – 11.1
Week 240
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
7.2
3.3 – 11.1
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240Secondary· Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240
Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value
Week 48, n=182
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-3.3
± 4.84
Week 96, n= 176
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.7
± 5.60
Week 144, n= 175
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-5.1
± 5.85
Week 192, n=167
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-5.1
± 7.82
Week 240, n= 131
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-6.2
± 5.55
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240Secondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.
Week 48, n=191
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
81.2
75.3 – 87.0
Week 96, n=188
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
88.8
84.1 – 93.6
Week 144, n=185
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
94.1
90.4 – 97.7
Week 192, n=174
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
97.7
95.2 – 100.0
Week 240, n=160
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
99.4
97.8 – 100.0
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNASecondary· Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240
Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Week 48, n=191
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.2
± 1.40
Week 96, n=188
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.3
± 1.44
Week 144, n=185
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.3
± 1.48
Week 192, n=174
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.2
± 1.50
Week 240, n=160
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
-4.3
± 1.46
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at BaselineSecondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.
Week 48, n=97
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
63.9
53.8 – 74.0
Week 96, n= 97
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
66.0
56.0 – 75.9
Week 144, n=96
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
70.8
61.2 – 80.4
Week 192, n=93
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
82.8
74.6 – 91.0
Week 240, n=87
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
82.8
74.2 – 91.3
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.Secondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.
Week 48, HBeAg Loss, n=94
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
18.1
9.8 – 26.4
Week 48, HBeAg Seroconversion, n=94
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
9.6
3.1 – 16.1
Week 96, HBeAg , n=94
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
33.0
22.9 – 43.0
Week 96, HBeAg Seroconversion, n=94
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
14.9
7.2 – 22.6
Week 144, HBeAg Loss, n=90
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
35.6
24.5 – 45.1
Week 144, HBeAg Seroconversion, n=90
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
14.4
6.5 – 21.8
Week 192, HBeAg Loss, n=90
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
47.8
36.4 – 58.1
Week 192, HBeAg Seroconversion, n=90
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
16.7
8.3 – 24.7
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240Secondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.
Week 48, HBsAg Loss, n=97
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
1.0
0.0 – 3.6
Week 48, HBsAg Seroconversion, n=97
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
1.0
0.0 – 3.6
Week 96, HBsAg , n=93
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
0.0 – 0.5
Week 96, HBsAg Seroconversion, n=93
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
0.0 – 0.5
Week 144, HBsAg Loss, n=93
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
3.2
0.0 – 7.4
Week 144, HBsAg Seroconversion, n=93
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
0.0 – 0.5
Week 192, HBsAg Loss, n=89
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
4.5
0.0 – 9.4
Week 192, HBsAg Seroconversion, n=89
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
2.2
0.0 – 5.9
Percentage of Participants Who Experienced Viral BreakthroughSecondary· Week 48, Week 96, Week 144, Week 192 and Week 240
Viral breakthrough was defined as \>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.
Week 48, n=195
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
NA – NA
Week 96, n=195
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0
NA – NA
Week 144, n=185
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0.5
0.0 – 1.9
Week 192, n=180
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
1.1
0.0 – 2.9
Week 240, n=161
Group
Value
95% CI
Tenofovir Disoproxil Fumarate 300 mg
0.6
0.0 – 2.1
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tenofovir Disoproxil Fumarate 300 mg
Serious: 34/195 (17%)
Deaths: 2/195
Serious adverse events (29 terms)
Reaction
System
Tenofovir Disoproxil Fumar…
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Cholelithiasis
Hepatobiliary disorders
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Ovarian germ cell teratoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Foot fracture
Injury, poisoning and procedural complications
—
Lower limb fracture
Injury, poisoning and procedural complications
—
Post procedural bile leak
Injury, poisoning and procedural complications
—
Radius fracture
Injury, poisoning and procedural complications
—
Spinal compression fracture
Injury, poisoning and procedural complications
—
Tibia fracture
Injury, poisoning and procedural complications
—
Bile duct stone
Hepatobiliary disorders
—
Cholecystitis
Hepatobiliary disorders
—
Cholecystitis acute
Hepatobiliary disorders
—
Hepatic cirrhosis
Hepatobiliary disorders
—
Pneumonia
Infections and infestations
—
Upper respiratory tract infection
Infections and infestations
—
Rheumatic fever
Musculoskeletal and connective tissue disorders
—
Synovial cyst
Musculoskeletal and connective tissue disorders
—
Nasal polyps
Respiratory, thoracic and mediastinal disorders
—
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
—
Rhinitis hypertrophic
Respiratory, thoracic and mediastinal disorders
—
Urticaria
Skin and subcutaneous tissue disorders
—
Vertigo positional
Ear and labyrinth disorders
—
Uterine adhesions
Reproductive system and breast disorders
—
Ureterolithiasis
Renal and urinary disorders
—
Other adverse events (133 terms — click to expand)
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease progression. Majority of Chinese patients are infected with genotype B and C HBV, which is different from Caucasian counterparts. This prospective multi-center cohort open-label study is designed to investigate the long-term effect of TDF on prevention of HCC and disease progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05355467 — Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Bee
· Phase 4
· completed
NCT03357822 — A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B
· Phase 4
· unknown
NCT02937779 — Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission
· Phase 4
· unknown
NCT03032536 — Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxi
· Phase 1
· terminated
Other recruiting trials for Hepatitis B, Chronic
Currently open trials in the same condition.
NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
· Phase 2
· recruiting
NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
· recruiting
NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
· Phase 2
· active not recruiting
NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
· recruiting
NCT05937178 — Real-world Study Optimizing Nucleotide-analogues
· recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 14 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02224456.