Trial · NCT00116805
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
NCT00116805, Phase 3, Completed, Gilead Sciences; results first posted 2010-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B. Trials, record NCT00116805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00116805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
- NCT number
- NCT00116805
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 266 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Hepatitis B
- Interventions
- TDF, ADV, TDF placebo, ADV placebo, FTC/TDF
- First posted
- 2005-07-01
- Last updated
- 2017-03-09
- Other registries' IDs
- eudract:2004-005120-41
- Results first posted
- 2010-05-19
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48 | Baseline; Week 48 | Complete response was a composite endpoint defined as histological response and HBV DNA \< 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40. |
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48 | Week 48 | |
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | Week 96 | |
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | Weeks 144, 192, 240, 288, 336, and 384 | |
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480 | Weeks 432 and 480 | |
| Secondary | Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480 | |
| Secondary | Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480 | |
| Secondary | Percentage of Participants With Histological Response at Week 48 | Baseline; Week 48 | Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. |
| Secondary | Percentage of Participants With Histological Response at Week 240 | Baseline; Week 240 | Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. |
| Secondary | Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48 | Baseline; Week 48 | The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
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 HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48 | Baseline; Week 48 | Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48 | Week 48 | Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | Week 96 | Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who discontinued study unless the discontinuation was unrelated to protocol criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | Weeks 144, 192, 240, 288, 336, and 384 | Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480 | Weeks 432 and 480 | Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis. | log10 IU/mL | MEAN |
| SECONDARY | Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480 | Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis. | log10 IU/mL | MEAN |
| SECONDARY | Percentage of Participants With Histological Response at Week 48 | Baseline; Week 48 | Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Histological Response at Week 240 | Baseline; Week 240 | Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48 | Baseline; Week 48 | Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. | units on a scale | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group400
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 HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48 | TDF-TDF | 66.5 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48 | ADV 10 mg | 12.2 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48 | TDF-TDF | 76.1 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48 | ADV-TDF | 13.3 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | TDF-TDF | 77.6 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | ADV-TDF | 77.9 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | TDF-TDF | Week 144 | 71.7 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | ADV-TDF | Week 144 | 70.5 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | TDF-TDF | Week 192 | 67.9 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384 | ADV-TDF | Week 192 | 71.6 | percentage of participants |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period Through Week 48 | STARTED | TDF-TDF | 176 | |
| Double-blind Period Through Week 48 | STARTED | ADV-TDF | 90 | |
| Double-blind Period Through Week 48 | COMPLETED | TDF-TDF | 165 | |
| Double-blind Period Through Week 48 | COMPLETED | ADV-TDF | 85 | |
| Double-blind Period Through Week 48 | NOT COMPLETED | TDF-TDF | 11 | |
| Double-blind Period Through Week 48 | NOT COMPLETED | ADV-TDF | 5 | |
| Open-label Period Weeks 49 - 96 | STARTED | TDF-TDF | 154 | |
| Open-label Period Weeks 49 - 96 | STARTED | ADV-TDF | 84 | |
| Open-label Period Weeks 49 - 96 | COMPLETED | TDF-TDF | 144 | |
| Open-label Period Weeks 49 - 96 | COMPLETED | ADV-TDF | 83 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events240
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 | Abdominal pain | Gastrointestinal disorders | Double-Blind TDF | 6 | 176 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind ADV | 3 | 90 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label TDF | 22 | 238 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Double-Blind TDF | 15 | 176 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Double-Blind ADV | 4 | 90 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Open-Label TDF | 25 | 238 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind TDF | 12 | 176 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind ADV | 3 | 90 | |
| other | Diarrhoea | Gastrointestinal disorders | Open-Label TDF | 12 | 238 | |
| other | Nausea | Gastrointestinal disorders | Double-Blind TDF | 26 | 176 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind TDF | ||
| Total, all-cause mortality | Double-Blind ADV | ||
| Total, all-cause mortality | Open-Label TDF | ||
| Total, other adverse events | Double-Blind TDF | 97 | 176 |
| Total, other adverse events | Double-Blind ADV | 49 | 90 |
| Total, other adverse events | Open-Label TDF | 165 | 238 |
| Total, serious adverse events | Double-Blind TDF | 15 | 176 |
| Total, serious adverse events | Double-Blind ADV | 7 | 90 |
| Total, serious adverse events | Open-Label TDF | 41 | 238 |
Source ClinicalTrials.gov
Papers16
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/NCT00116805
GET https://conductscience.org/api/trials/v1/NCT00116805/registered?page=2