Trial · NCT01940471
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
NCT01940471, Phase 3, Completed, Gilead Sciences; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen. Trials, record NCT01940471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01940471
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
- NCT number
- NCT01940471
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 875 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- HBeAg-positive Chronic Hepatitis B
- Interventions
- TAF, TDF, TAF Placebo, TDF Placebo
- First posted
- 2013-09-12
- Last updated
- 2023-10-10
- Other registries' IDs
- eudract:2013-000636-10
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 | Week 48 | |
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 | Week 48 | |
| Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Baseline, Week 48 | |
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline at Week 48 in Serum Creatinine | Baseline, Week 48 | |
| Other | Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 | Week 48 | Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 | Week 48 | Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Baseline, Week 48 | Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis. | percentage change | MEAN |
| SECONDARY | Percent Change From Baseline in Spine BMD at Week 48 | Baseline, Week 48 | Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis. | percentage change | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Serum Creatinine | Baseline, Week 48 | Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis. | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48 | Up to 48 weeks | Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 | TAF 25 mg | 63.9 | percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 | TDF 300 mg | 66.8 | percentage of participants | ||
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 | TAF 25 mg | 10.3 | percentage of participants | ||
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 | TDF 300 mg | 8.1 | percentage of participants | ||
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | TAF 25 mg | -0.100 | Standard Deviation 2.2912 | percentage change | |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | TDF 300 mg | -1.715 | Standard Deviation 2.5723 | percentage change | |
| Percent Change From Baseline in Spine BMD at Week 48 | TAF 25 mg | -0.417 | Standard Deviation 2.9343 | percentage change | |
| Percent Change From Baseline in Spine BMD at Week 48 | TDF 300 mg | -2.294 | Standard Deviation 3.1331 | percentage change | |
| Change From Baseline at Week 48 in Serum Creatinine | TAF 25 mg | 0.009 | Standard Deviation 0.1238 | mg/dL | |
| Change From Baseline at Week 48 in Serum Creatinine | TDF 300 mg | 0.026 | Standard Deviation 0.0948 | mg/dL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Double-blind Phase | STARTED | TAF 25 mg | 582 | |
| Period 1: Double-blind Phase | STARTED | TDF 300 mg | 293 | |
| Period 1: Double-blind Phase | STARTED | TAF 25 mg to TAF 25 mg | 0 | |
| Period 1: Double-blind Phase | STARTED | TDF 300 mg to TAF 25 mg | 0 | |
| Period 1: Double-blind Phase | COMPLETED | TAF 25 mg | 515 | |
| Period 1: Double-blind Phase | COMPLETED | TDF 300 mg | 253 | |
| Period 1: Double-blind Phase | COMPLETED | TAF 25 mg to TAF 25 mg | 0 | |
| Period 1: Double-blind Phase | COMPLETED | TDF 300 mg to TAF 25 mg | 0 | |
| Period 1: Double-blind Phase | NOT COMPLETED | TAF 25 mg | 67 | |
| Period 1: Double-blind Phase | NOT COMPLETED | TDF 300 mg | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events588
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Phase: TAF 25 mg | 35 | 581 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Phase: TDF 300 mg | 19 | 292 | |
| other | Diarrhoea | Gastrointestinal disorders | Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg | 13 | 514 | |
| other | Diarrhoea | Gastrointestinal disorders | Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg | 6 | 253 | |
| other | Dyspepsia | Gastrointestinal disorders | Double-blind Phase: TAF 25 mg | 32 | 581 | |
| other | Dyspepsia | Gastrointestinal disorders | Double-blind Phase: TDF 300 mg | 16 | 292 | |
| other | Dyspepsia | Gastrointestinal disorders | Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg | 16 | 514 | |
| other | Dyspepsia | Gastrointestinal disorders | Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg | 9 | 253 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Double-blind Phase: TAF 25 mg | 19 | 581 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Double-blind Phase: TDF 300 mg | 10 | 292 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Phase: TAF 25 mg | 2 | 582 |
| Total, all-cause mortality | Double-blind Phase: TDF 300 mg | 1 | 293 |
| Total, all-cause mortality | Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg | 0 | 514 |
| Total, all-cause mortality | Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg | 0 | 253 |
| Total, other adverse events | Double-blind Phase: TAF 25 mg | 290 | 581 |
| Total, other adverse events | Double-blind Phase: TDF 300 mg | 143 | 292 |
| Total, other adverse events | Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg | 168 | 514 |
| Total, other adverse events | Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg | 100 | 253 |
| Total, serious adverse events | Double-blind Phase: TAF 25 mg | 44 | 581 |
| Total, serious adverse events | Double-blind Phase: TDF 300 mg | 20 | 292 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01940471
GET https://conductscience.org/api/trials/v1/NCT01940471/flow?page=2