Trial · NCT01277601
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
NCT01277601, Phase 4, Completed, Gilead Sciences; results first posted 2015-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B. Trials, record NCT01277601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01277601
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
- NCT number
- NCT01277601
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 751 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Hepatitis B
- Interventions
- TDF, Peg-IFN
- First posted
- 2011-01-17
- Last updated
- 2016-08-26
- Other registries' IDs
- eudract:2010-024586-45
- Results first posted
- 2015-09-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. |
| Secondary | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. |
| Secondary | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Baseline; Weeks 96 and 120 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis. |
| Secondary | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Baseline; Weeks 72, 96, and 120 | HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120. |
| Secondary | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | Baseline; Week 72 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72. |
| Secondary | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | Baseline; Week 96 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96. |
| Secondary | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | Baseline; Week 120 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120. |
| Secondary | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | Week 72 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72. |
| Secondary | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | Week 96 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96. |
| Secondary | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | Week 120 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Baseline; Weeks 96 and 120 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Baseline; Weeks 72, 96, and 120 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | Baseline; Week 72 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | Baseline; Week 96 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | Baseline; Week 120 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | Week 72 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | Week 96 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | Week 120 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group134
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 HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | TDF+Peg-IFN 48 Weeks | 9.05 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | TDF 120 Weeks | 0.00 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Peg-IFN 48 Weeks | 2.84 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | TDF 48 Weeks + Peg-IFN 16 Weeks | 2.83 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | TDF 120 Weeks | 0.00 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Peg-IFN 48 Weeks | 2.84 | percentage of participants | ||
| Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | TDF+Peg-IFN 48 Weeks | Week 96 | 9.69 | percentage of participants | |
| Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | TDF 48 Weeks + Peg-IFN 16 Weeks | Week 96 | 3.49 | percentage of participants | |
| Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | TDF 120 Week | Week 96 | 0.00 | percentage of participants | |
| Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Peg-IFN 48 Weeks | Week 96 | 2.84 | percentage of participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TDF+Peg-IFN 48 Weeks | 188 | |
| Overall Study | STARTED | TDF 48 Weeks + Peg-IFN 16 Weeks | 187 | |
| Overall Study | STARTED | TDF 120 Weeks | 190 | |
| Overall Study | STARTED | Peg-IFN 48 Weeks | 186 | |
| Overall Study | COMPLETED | TDF+Peg-IFN 48 Weeks | 151 | |
| Overall Study | COMPLETED | TDF 48 Weeks + Peg-IFN 16 Weeks | 139 | |
| Overall Study | COMPLETED | TDF 120 Weeks | 163 | |
| Overall Study | COMPLETED | Peg-IFN 48 Weeks | 150 | |
| Overall Study | NOT COMPLETED | TDF+Peg-IFN 48 Weeks | 37 | |
| Overall Study | NOT COMPLETED | TDF 48 Weeks + Peg-IFN 16 Weeks | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events560
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 | Neutropenia | Blood and lymphatic system disorders | TDF+Peg-IFN 48 Weeks (Not Retreated) | 15 | 186 | |
| other | Neutropenia | Blood and lymphatic system disorders | TDF+Peg-IFN 48 Weeks (Retreated) | 0 | 112 | |
| other | Neutropenia | Blood and lymphatic system disorders | TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) | 11 | 184 | |
| other | Neutropenia | Blood and lymphatic system disorders | TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) | 1 | 115 | |
| other | Neutropenia | Blood and lymphatic system disorders | TDF 120 Weeks | 0 | 185 | |
| other | Neutropenia | Blood and lymphatic system disorders | Peg-IFN 48 Weeks (Not Retreated) | 15 | 185 | |
| other | Neutropenia | Blood and lymphatic system disorders | Peg-IFN 48 Weeks (Retreated) | 0 | 117 | |
| other | Abdominal pain | Gastrointestinal disorders | TDF+Peg-IFN 48 Weeks (Not Retreated) | 7 | 186 | |
| other | Abdominal pain | Gastrointestinal disorders | TDF+Peg-IFN 48 Weeks (Retreated) | 1 | 112 | |
| other | Abdominal pain | Gastrointestinal disorders | TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) | 6 | 184 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDF+Peg-IFN 48 Weeks (Not Retreated) | ||
| Total, all-cause mortality | TDF+Peg-IFN 48 Weeks (Retreated) | ||
| Total, all-cause mortality | TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) | ||
| Total, all-cause mortality | TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) | ||
| Total, all-cause mortality | TDF 120 Weeks | ||
| Total, all-cause mortality | Peg-IFN 48 Weeks (Not Retreated) | ||
| Total, all-cause mortality | Peg-IFN 48 Weeks (Retreated) | ||
| Total, other adverse events | TDF+Peg-IFN 48 Weeks (Not Retreated) | 147 | 186 |
| Total, other adverse events | TDF+Peg-IFN 48 Weeks (Retreated) | 26 | 112 |
| Total, other adverse events | TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) | 142 | 184 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
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/NCT01277601
GET https://conductscience.org/api/trials/v1/NCT01277601/results?page=2