Trial · NCT02224456
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
NCT02224456, Phase 4, Completed, GlaxoSmithKline; results first posted 2022-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis. Trials, record NCT02224456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224456
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
- NCT number
- NCT02224456
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 197 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B, Chronic
- Interventions
- Tenofovir disoproxil fumarate
- First posted
- 2014-08-25
- Last updated
- 2022-02-14
- Results first posted
- 2022-02-14
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 | 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 typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). |
| Primary | Percentage of Participants With Disease Progression at Week 240 | 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. |
| Secondary | Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | 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 typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). |
| Secondary | Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | 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 typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method). |
| Secondary | Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240 | 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 disease progression has been presented along with 95% CI (Wald method). |
| Secondary | Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240 | 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 |
| Secondary | 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 240 | 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. |
| Secondary | Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA | 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. |
| Secondary | 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 Baseline | 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. |
| Secondary | 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. | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 | Week 240 | Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication. | Events per person-year | NUMBER |
| PRIMARY | Percentage of Participants With Disease Progression at Week 240 | Week 240 | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | Week 48, Week 96, Week 144 and Week 192 | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240 | Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240 | Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles. | Kilopascals | MEAN |
| SECONDARY | 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 240 | Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA | Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles. | Log 10 (IU/mL) | MEAN |
| SECONDARY | 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 Baseline | Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles. | Percentage of participants | NUMBER |
| SECONDARY | 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. | Week 48, Week 96, Week 144, Week 192 and Week 240 | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.) | Percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group211
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 | Tenofovir Disoproxil Fumarate 300 mg | 6.045 | Events per person-year | ||
| Percentage of Participants With Disease Progression at Week 240 | Tenofovir Disoproxil Fumarate 300 mg | 7.2 | Percentage of participants | ||
| Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | Tenofovir Disoproxil Fumarate 300 mg | Week 48 | 0 | Participants | |
| Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | Tenofovir Disoproxil Fumarate 300 mg | Week 96 | 0 | Participants | |
| Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | Tenofovir Disoproxil Fumarate 300 mg | Week 144 | 4 | Participants | |
| Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 | Tenofovir Disoproxil Fumarate 300 mg | Week 192 | 9 | Participants | |
| Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | Tenofovir Disoproxil Fumarate 300 mg | Week 48 | 0 | 95% Confidence Interval NA to NA | Percentage of participants |
| Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | Tenofovir Disoproxil Fumarate 300 mg | Week 96 | 0 | 95% Confidence Interval NA to NA | Percentage of participants |
| Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | Tenofovir Disoproxil Fumarate 300 mg | Week 144 | 2.1 | 95% Confidence Interval 0.0 to 4.3 | Percentage of participants |
| Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 | Tenofovir Disoproxil Fumarate 300 mg | Week 192 | 4.6 | 95% Confidence Interval 1.4 to 7.8 | Percentage of participants |
1 to 10 of 211Source ClinicalTrials.gov
See all 211 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tenofovir Disoproxil Fumarate 300 mg | 197 | |
| Overall Study | COMPLETED | Tenofovir Disoproxil Fumarate 300 mg | 161 | |
| Overall Study | NOT COMPLETED | Tenofovir Disoproxil Fumarate 300 mg | 36 |
Source ClinicalTrials.gov
Adverse events162
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 | Upper respiratory tract infection | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 36 | 195 | |
| other | Urinary tract infection | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 11 | 195 | |
| other | Nasopharyngitis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 3 | 195 | |
| other | Pharyngitis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 2 | 195 | |
| other | Pneumonia | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 2 | 195 | |
| other | Pulmonary tuberculosis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 2 | 195 | |
| other | Urethritis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 1 | 195 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 1 | 195 | |
| other | Rhinitis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 1 | 195 | |
| other | Myringitis | Infections and infestations | Tenofovir Disoproxil Fumarate 300 mg | 1 | 195 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenofovir Disoproxil Fumarate 300 mg | 2 | 195 |
| Total, other adverse events | Tenofovir Disoproxil Fumarate 300 mg | 129 | 195 |
| Total, serious adverse events | Tenofovir Disoproxil Fumarate 300 mg | 34 | 195 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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