Trial · NCT01480284
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
NCT01480284, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue. Trials, record NCT01480284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01480284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
- NCT number
- NCT01480284
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 166 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B, Chronic
- Interventions
- GSK548470 300 mg tablet, ETV 0.5 mg capsule
- First posted
- 2011-11-28
- Last updated
- 2016-08-10
- Results first posted
- 2013-10-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Serum HBV DNA Level at Week 24 | Baseline and Week 24 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Baseline, Week 48 and Week 96 | The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated HBsAg category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, and \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg \<3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and \>=6.0) (Log kilo unit per liter \[KU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Serum HBV DNA Level at Week 24 | Baseline and Week 24 | Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method. | log10 copies/milliliter (copies/mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Baseline, Week 48 and Week 96 | Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation. | log10 copies/mL | MEAN |
| SECONDARY | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | FAS Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value \> ULN at Baseline. | Participants | NUMBER |
| SECONDARY | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | FAS Population. Only participants with positive HBeAg at Baseline were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | FAS Population. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | FAS Population | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | FAS Population | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Serum HBV DNA Level at Week 24 | TDF 300 mg OD | -4.63 | Standard Error 0.044 | log10 copies/milliliter (copies/mL) | |
| Mean Change From Baseline in Serum HBV DNA Level at Week 24 | ETV 0.5 mg OD | -4.50 | Standard Error 0.063 | log10 copies/milliliter (copies/mL) | |
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | TDF 300 mg OD | Week 48 | -4.86 | Standard Deviation 1.353 | log10 copies/mL |
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | ETV 0.5 mg OD | Week 48 | -4.85 | Standard Deviation 0.916 | log10 copies/mL |
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | TDF 300 mg OD | Week 96 | -4.96 | Standard Deviation 1.445 | log10 copies/mL |
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | ETV 0.5 mg OD | Week 96 | NA | Standard Deviation NA | log10 copies/mL |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | TDF 300 mg OD | Week 24 | 59 | Participants | |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | ETV 0.5 mg OD | Week 24 | 22 | Participants | |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | TDF 300 mg OD | Week 48 | 84 | Participants | |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | ETV 0.5 mg OD | Week 48 | 37 | Participants |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 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 300 mg OD | 110 | |
| Overall Study | STARTED | ETV 0.5 mg OD | 56 | |
| Overall Study | COMPLETED | TDF 300 mg OD | 102 | |
| Overall Study | COMPLETED | ETV 0.5 mg OD | 56 | |
| Overall Study | NOT COMPLETED | TDF 300 mg OD | 8 | |
| Overall Study | NOT COMPLETED | ETV 0.5 mg OD | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Nasopharyngitis | Infections and infestations | TDF 300 mg OD | 48 | 109 | |
| other | Nasopharyngitis | Infections and infestations | ETV 0.5 mg OD | 24 | 56 | |
| other | Headache | Nervous system disorders | TDF 300 mg OD | 16 | 109 | |
| other | Headache | Nervous system disorders | ETV 0.5 mg OD | 5 | 56 | |
| other | Blood creatine phosphokinase increased | Investigations | TDF 300 mg OD | 11 | 109 | |
| other | Blood creatine phosphokinase increased | Investigations | ETV 0.5 mg OD | 4 | 56 | |
| other | Influenza | Infections and infestations | TDF 300 mg OD | 10 | 109 | |
| other | Influenza | Infections and infestations | ETV 0.5 mg OD | 3 | 56 | |
| other | Pharyngitis | Infections and infestations | TDF 300 mg OD | 10 | 109 | |
| other | Pharyngitis | Infections and infestations | ETV 0.5 mg OD | 2 | 56 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDF 300 mg OD | ||
| Total, all-cause mortality | ETV 0.5 mg OD | ||
| Total, other adverse events | TDF 300 mg OD | 83 | 109 |
| Total, other adverse events | ETV 0.5 mg OD | 40 | 56 |
| Total, serious adverse events | TDF 300 mg OD | 7 | 109 |
| Total, serious adverse events | ETV 0.5 mg OD | 2 | 56 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28374496 | DERIVED |
Source PubMed
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 300 mg OD vs ETV 0.5 mg OD: Number of Participants With Virological Breakthrough Through End of the Study | Trial comparisons |
| TDF 300 mg OD vs ETV 0.5 mg OD: 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/NCT01480284
GET https://conductscience.org/api/trials/v1/NCT01480284/results?page=2