Trial · NCT00940485
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
NCT00940485, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-02-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B. Trials, record NCT00940485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00940485
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
- NCT number
- NCT00940485
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 200 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis B, Chronic
- Interventions
- entecavir, entecavir, peginterferon alfa-2a [Pegasys]
- First posted
- 2009-07-16
- Last updated
- 2016-03-25
- Results first posted
- 2016-02-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 | At Week 48 | Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe). |
| Secondary | Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | At Week 48 | Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg. |
| Secondary | Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | At Week 48 | Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA \< 1000 copies/mL was reported. |
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | At Week 48 | Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative. |
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | At Week 48 | Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen) |
| Secondary | Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 | At Week 48 | Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value \> upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point. |
| Secondary | Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time | Up to Week 48 | Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. |
| Secondary | Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time | Up to Week 48 | Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. |
| Secondary | Number of Participants With Incidence of Adverse Events and Serious Adverse Events | Up to Week 48 | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Secondary | Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event | Up to Week 48 | Participants with clinically significant laboratory abnormalities which were captured as an AE (at the \>=5% threshold) were presented. |
Source ClinicalTrials.gov
Outcomes10
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 Hepatitis B Envelope Antigen Seroconversion at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 | At Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Percentage of participants | NUMBER |
| SECONDARY | Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time | Up to Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed. | PEIU/ml) | MEAN |
| SECONDARY | Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time | Up to Week 48 | Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed. | IU/ml | MEAN |
| SECONDARY | Number of Participants With Incidence of Adverse Events and Serious Adverse Events | Up to Week 48 | Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not. | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event | Up to Week 48 | Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
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 Hepatitis B Envelope Antigen Seroconversion at Week 48 | Peginterferon Alfa-2a + Entecavir | 14.89 | 95% Confidence Interval 8.39 to 23.72 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 | Entecavir | 6.12 | 95% Confidence Interval 2.28 to 12.85 | Percentage of participants | |
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | Peginterferon Alfa-2a + Entecavir | 62.77 | 95% Confidence Interval 52.18 to 72.52 | Percentage of participants | |
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | Entecavir | 60.20 | 95% Confidence Interval 49.82 to 69.96 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | Peginterferon Alfa-2a + Entecavir | 62.77 | 95% Confidence Interval 52.18 to 72.52 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | Entecavir | 91.84 | 95% Confidence Interval 84.55 to 96.41 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | Peginterferon Alfa-2a + Entecavir | 8.51 | 95% Confidence Interval 3.75 to 16.08 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | Entecavir | 0 | 95% Confidence Interval 0 to 3.69 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | Peginterferon Alfa-2a + Entecavir | 4.26 | 95% Confidence Interval 1.17 to 10.54 | Percentage of participants | |
| Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | Entecavir | 0 | 95% Confidence Interval 0 to 3.69 | Percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peginterferon Alfa-2a + Entecavir | 97 | |
| Overall Study | STARTED | Entecavir | 100 | |
| Overall Study | COMPLETED | Peginterferon Alfa-2a + Entecavir | 82 | |
| Overall Study | COMPLETED | Entecavir | 93 | |
| Overall Study | NOT COMPLETED | Peginterferon Alfa-2a + Entecavir | 15 | |
| Overall Study | NOT COMPLETED | Entecavir | 7 |
Source ClinicalTrials.gov
Adverse events86
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 | Haemoglobin decreased | Investigations | Peginterferon Alfa-2a + Entecavir | 6 | 97 | |
| other | Haemoglobin decreased | Investigations | Entecavir | 0 | 100 | |
| other | Aspartate aminotransferase increased | Investigations | Peginterferon Alfa-2a + Entecavir | 8 | 97 | |
| other | Aspartate aminotransferase increased | Investigations | Entecavir | 0 | 100 | |
| other | Alanine aminotransferase increased | Investigations | Peginterferon Alfa-2a + Entecavir | 9 | 97 | |
| other | Alanine aminotransferase increased | Investigations | Entecavir | 0 | 100 | |
| other | Platelet count decreased | Investigations | Peginterferon Alfa-2a + Entecavir | 42 | 97 | |
| other | Platelet count decreased | Investigations | Entecavir | 0 | 100 | |
| other | Neutrophil count decreased | Investigations | Peginterferon Alfa-2a + Entecavir | 53 | 97 | |
| other | Neutrophil count decreased | Investigations | Entecavir | 0 | 100 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peginterferon Alfa-2a + Entecavir | ||
| Total, all-cause mortality | Entecavir | ||
| Total, other adverse events | Peginterferon Alfa-2a + Entecavir | 65 | 97 |
| Total, other adverse events | Entecavir | 5 | 100 |
| Total, serious adverse events | Peginterferon Alfa-2a + Entecavir | 6 | 97 |
| Total, serious adverse events | Entecavir | 0 | 100 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Peginterferon Alfa-2a + Entecavir vs Entecavir: serious adverse events |
Source 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/NCT00940485
GET https://conductscience.org/api/trials/v1/NCT00940485/results?page=2