Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
Primary
· Week 48
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 61.0 | |
| Double-Blind: TDF 300 mg | 68.4 |
Last reviewed · How we verify
NCT02836249
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
Completed
Phase 3
Results posted
Last updated 15 October 2024
What this trial tests
Phase 3 trial testing TAF in HBV in 181 participants. Completed in 31 August 2023.
Timeline
19 June 2015
Primary endpoint
21 March 2017
21 March 2017
31 August 2023
Quick facts
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 181 |
| Start date | 19 June 2015 |
| Primary completion | 21 March 2017 |
| Estimated completion | 31 August 2023 |
| Sites | 25 locations across China |
Drugs / interventions tested
- TAF — full drug profile →
- TDF
- TAF Placebo
- TDF Placebo — full drug profile →
Conditions studied
- HBV — all drugs for HBV →
- Chronic HBV Infection — all drugs for Chronic HBV Infection →
Sponsor
Gilead Sciences — full company profile →
Who can join
18 and older, any sex, with HBV or Chronic HBV Infection. 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.
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48
Secondary
· Week 48
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 11.0 | |
| Double-Blind: TDF 300 mg | 8.8 |
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Secondary
· Baseline; Week 48
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 0.624 | ± 2.2731 |
| Double-Blind: TDF 300 mg | -1.507 | ± 2.4193 |
Percent Change From Baseline in Spine BMD at Week 48
Secondary
· Baseline; Week 48
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 0.683 | ± 3.3281 |
| Double-Blind: TDF 300 mg | -2.169 | ± 3.4503 |
Change From Baseline at Week 48 in Serum Creatinine
Secondary
· Baseline; Week 48
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | -0.003 | ± 0.0701 |
| Double-Blind: TDF 300 mg | 0.016 | ± 0.0920 |
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Secondary
· Up to 48 weeks
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.
Grade 1
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 24.4 | |
| Double-Blind: TDF 300 mg | 22.8 |
Grade 2
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 0.8 | |
| Double-Blind: TDF 300 mg | 3.5 |
Grade 3
| Group | Value | 95% CI |
|---|---|---|
| Double-Blind: TAF 25 mg | 0 | |
| Double-Blind: TDF 300 mg | 0 |
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Double-Blind: TAF 25 mg
Serious: 8/123 (7%)
Deaths: 0/123
Double-Blind: TDF 300 mg
Serious: 3/57 (5%)
Deaths: 0/57
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
Serious: 7/113 (6%)
Deaths: 1/113
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
Serious: 4/52 (8%)
Deaths: 0/52
Serious adverse events (27 terms)
| Reaction | System | Double-Blind: TAF 25 mg | Double-Blind: TDF 300 mg | Open-label TAF Extension P… | Open-label TAF Extension P… |
|---|---|---|---|---|---|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Cardiac polyp | Cardiac disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Haematochezia | Gastrointestinal disorders | — | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Appendicitis | Infections and infestations | — | — | — | — |
| Infective exacerbation of bronchiectasis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — |
| Appendix cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Cerebral infarction | Nervous system disorders | — | — | — | — |
| Subarachnoid haemorrhage | Nervous system disorders | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — | — | — |
| Abnormal uterine bleeding | Reproductive system and breast disorders | — | — | — | — |
| Uterine polyp | Reproductive system and breast disorders | — | — | — | — |
| Cystic lung disease | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
Other adverse events (29 terms — click to expand)
| Reaction | System | Double-Blind: TAF 25 mg | Double-Blind: TDF 300 mg | Open-label TAF Extension P… | Open-label TAF Extension P… |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Hepatic steatosis | Hepatobiliary disorders | — | — | — | — |
| Hyperlipidaemia | Metabolism and nutrition disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Gallbladder polyp | Hepatobiliary disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — | — | — | — |
| Renal cyst | Renal and urinary disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Osteopenia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Hepatic cyst | Hepatobiliary disorders | — | — | — | — |
| Blood parathyroid hormone increased | Investigations | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Suspected COVID-19 | Infections and infestations | — | — | — | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — | — | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — | — | — |
| Proteinuria | Renal and urinary disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Tonsillitis | Infections and infestations | — | — | — | — |
| Amylase increased | Investigations | — | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — | — |
| Creatinine renal clearance decreased | Investigations | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
Most-reported serious reactions: Hepatic cancer, Cardiac polyp, Ascites, Haematochezia, Haemorrhoids, Pyrexia, Cholecystitis acute, Cholelithiasis.
Data from ClinicalTrials.gov NCT02836249 adverse events section.
Sponsor's own description
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
3-year Treatment of Tenofovir Alafenamide <i>vs</i>. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China.
Hou J, Ning Q, Duan Z, Chen Y, et al · · 2021 · cited 28× · PMID 34221918 · DOI 10.14218/jcth.2020.00145 -
Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B.
Lim YS, Chan HLY, Ahn SH, Seto WK, et al · · 2023 · cited 13× · PMID 37771546 · DOI 10.1016/j.jhepr.2023.100847 -
Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients.
Hou J, Ning Q, Duan Z, Chen Y, et al · · 2024 · cited 4× · PMID 38779514 · DOI 10.14218/jcth.2023.00417 -
Eight-year Results from Two Randomized Phase 3 Trials of Tenofovir Alafenamide for Chronic Hepatitis B Virus Infection in China.
Hou J, Ning Q, Duan Z, Chen Y, et al · · 2026 · PMID 41810101 · DOI 10.14218/jcth.2025.00438
Verify or expand the search:
- PubMed search for NCT02836249
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02836249 (US National Library of Medicine, public domain)
- 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 Gilead Sciences
- Last refreshed: 15 October 2024
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/NCT02836249.
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