Trial · NCT01300234
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
NCT01300234, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB). Trials, record NCT01300234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01300234
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
- NCT number
- NCT01300234
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 512 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B
- Interventions
- Tenofovir disoproxil fumarate (TDF) tablets, Adefovir dipivoxil (ADV) tablets
- First posted
- 2011-02-21
- Last updated
- 2018-07-13
- Results first posted
- 2013-08-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | Week 48 | The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) \<400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Weeks 96, 144, 192, and 240 | The number of participants with HBV DNA \<400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Baseline, Weeks 48, 96, 144, 192 and 240 | Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Baseline; Weeks 48, 96, 144, 192 and 240 | Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter \[U/L\]). Values at Day 0 were considered as Baseline values. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Baseline; Week 48 and Week 240 | Histological improvement is defined as a reduction of \>=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS \>=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 \[best\] to 14 \[worst\]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation. |
| Secondary | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Weeks 24, 48, 96, 144, 192 and 240 | HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240. |
| Secondary | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Weeks 24, 48, 96, 144, 192 and 240 | HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. |
| Secondary | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Weeks 24, 48, 96, 144, 192 and 240 | HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. |
| Secondary | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | Week 24 to Week 48 | Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A "non-completers equal failures" approach was used for the analysis in ITT population. |
| Secondary | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | Week 96 to Week 240 | Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A "non-completers equal failures" approach was used for the analysis in ITT population. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | Week 48 | Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication. | Participants | NUMBER |
| SECONDARY | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Weeks 96, 144, 192, and 240 | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Baseline, Weeks 48, 96, 144, 192 and 240 | ITT Population. | log10 copies/mL | MEAN |
| SECONDARY | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Baseline; Weeks 48, 96, 144, 192 and 240 | ITT Population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Baseline; Week 48 and Week 240 | ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Participants | NUMBER |
| SECONDARY | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Weeks 24, 48, 96, 144, 192 and 240 | ITT Population. Only those participants with data available at specific time point were analyzed | Participants | NUMBER |
| SECONDARY | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Weeks 24, 48, 96, 144, 192 and 240 | ITT Population. Only those participants with data available at specific time point were analyzed. | Participants | NUMBER |
| SECONDARY | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Weeks 24, 48, 96, 144, 192 and 240 | ITT Population. Only those participants with data available at specific time point were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | Week 24 to Week 48 | ITT Population. Only those participants available at the indicated time points were assessed. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | Week 96 to Week 240 | ITT Population. | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group224
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | TDF 300 mg | HBeAg-positive, n=103, 99 | 79 | Participants | |
| Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | ADV 10 mg | HBeAg-positive, n=103, 99 | 18 | Participants | |
| Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | TDF 300 mg | HBeAg-negative, n=154, 153 | 149 | Participants | |
| Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | ADV 10 mg | HBeAg-negative, n=154, 153 | 109 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | TDF-TDF | Week 96, HBeAg-positive, n=103, 99 | 95 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | ADV-TDF | Week 96, HBeAg-positive, n=103, 99 | 92 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | TDF-TDF | Week 96, HBeAg-negative, n=154, 153 | 144 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | ADV-TDF | Week 96, HBeAg-negative, n=154, 153 | 143 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | TDF-TDF | Week 144, HBeAg-positive, n=103, 99 | 97 | Participants | |
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | ADV-TDF | Week 144, HBeAg-positive, n=103, 99 | 95 | Participants |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TDF-TDF | 257 | |
| Overall Study | STARTED | ADV-TDF | 255 | |
| Overall Study | COMPLETED | TDF-TDF | 229 | |
| Overall Study | COMPLETED | ADV-TDF | 228 | |
| Overall Study | NOT COMPLETED | TDF-TDF | 28 | |
| Overall Study | NOT COMPLETED | ADV-TDF | 27 |
Source ClinicalTrials.gov
Adverse events382
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 discomfort | Gastrointestinal disorders | TDF-TDF | 3 | 257 | |
| other | Abdominal discomfort | Gastrointestinal disorders | ADV-TDF | 2 | 252 | |
| other | Abdominal pain upper | Gastrointestinal disorders | TDF-TDF | 3 | 257 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ADV-TDF | 5 | 252 | |
| other | Alanine aminotransferase increased | Investigations | TDF-TDF | 16 | 257 | |
| other | Alanine aminotransferase increased | Investigations | ADV-TDF | 8 | 252 | |
| other | Asthenia | General disorders | TDF-TDF | 4 | 257 | |
| other | Asthenia | General disorders | ADV-TDF | 5 | 252 | |
| other | Bronchitis | Infections and infestations | TDF-TDF | 1 | 257 | |
| other | Bronchitis | Infections and infestations | ADV-TDF | 4 | 252 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDF-TDF | 1 | 257 |
| Total, all-cause mortality | ADV-TDF | 0 | 252 |
| Total, other adverse events | TDF-TDF | 140 | 257 |
| Total, other adverse events | ADV-TDF | 121 | 252 |
| Total, serious adverse events | TDF-TDF | 12 | 257 |
| Total, serious adverse events | ADV-TDF | 20 | 252 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TDF-TDF vs ADV-TDF: deaths from any cause | Trial comparisons |
| TDF-TDF vs ADV-TDF: serious adverse events | Trial comparisons |
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/NCT01300234
GET https://conductscience.org/api/trials/v1/NCT01300234/results?page=2