Trial · NCT00435825
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
NCT00435825, Phase 4, Completed, Hoffmann-La Roche; results first posted 2013-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB). Trials, record NCT00435825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00435825
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
- NCT number
- NCT00435825
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 551 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis B, Chronic
- Interventions
- peginterferon alfa-2a [Pegasys]
- First posted
- 2007-02-16
- Last updated
- 2013-06-25
- Results first posted
- 2013-06-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment. |
| Secondary | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Week 72 | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72. |
| Secondary | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg. |
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment. |
| Secondary | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg. |
| Secondary | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay. |
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported. |
| Secondary | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment) | Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported. |
| Secondary | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL. |
| Secondary | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL). |
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 | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Week 72 | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
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 Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 90 μg_24 Weeks | 14.08 | 95% Confidence Interval 8.82 to 20.91 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 180 μg_24 Weeks | 22.86 | 95% Confidence Interval 16.19 to 30.71 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 90 μg_48 Weeks | 25.76 | 95% Confidence Interval 18.54 to 34.09 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 180 μg_48 Weeks | 36.15 | 95% Confidence Interval 27.91 to 45.04 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Peginterferon Alfa-2a 90 μg_24 Weeks | 18.31 | 95% Confidence Interval 12.32 to 25.67 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Peginterferon Alfa-2a 180 μg_24 Weeks | 27.14 | 95% Confidence Interval 19.98 to 35.30 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Peginterferon Alfa-2a 90 μg_48 Weeks | 25.76 | 95% Confidence Interval 18.54 to 34.09 | Percentage of participants | |
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Peginterferon Alfa-2a 180 μg_48 Weeks | 36.15 | 95% Confidence Interval 27.91 to 45.04 | Percentage of participants | |
| Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 90 μg_24 Weeks | 14.79 | 95% Confidence Interval 9.39 to 21.71 | Percentage of participants | |
| Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | Peginterferon Alfa-2a 180 μg_24 Weeks | 22.86 | 95% Confidence Interval 16.19 to 30.71 | Percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peginterferon Alfa-2a 90 μg_24 Weeks | 141 | |
| Overall Study | STARTED | Peginterferon Alfa-2a 180 μg_24 Weeks | 136 | |
| Overall Study | STARTED | Peginterferon Alfa-2a 90 μg_48 Weeks | 138 | |
| Overall Study | STARTED | Peginterferon Alfa-2a 180 μg_48 Weeks | 136 | |
| Overall Study | Received Study Drug | Peginterferon Alfa-2a 90 μg_24 Weeks | 140 | |
| Overall Study | Received Study Drug | Peginterferon Alfa-2a 180 μg_24 Weeks | 136 | |
| Overall Study | Received Study Drug | Peginterferon Alfa-2a 90 μg_48 Weeks | 136 | |
| Overall Study | Received Study Drug | Peginterferon Alfa-2a 180 μg_48 Weeks | 136 | |
| Overall Study | Entered Follow-up | Peginterferon Alfa-2a 90 μg_24 Weeks | 140 | |
| Overall Study | Entered Follow-up | Peginterferon Alfa-2a 180 μg_24 Weeks | 132 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events144
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 | Pyrexia | General disorders | Peginterferon Alfa-2a 90 μg_24 Weeks | 40 | 144 | |
| other | Pyrexia | General disorders | Peginterferon Alfa-2a 180 μg_24 Weeks | 50 | 141 | |
| other | Pyrexia | General disorders | Peginterferon Alfa-2a 90 μg_48 Weeks | 43 | 132 | |
| other | Pyrexia | General disorders | Peginterferon Alfa-2a 180 μg_48 Weeks | 46 | 130 | |
| other | Fatigue | General disorders | Peginterferon Alfa-2a 90 μg_24 Weeks | 27 | 144 | |
| other | Fatigue | General disorders | Peginterferon Alfa-2a 180 μg_24 Weeks | 20 | 141 | |
| other | Fatigue | General disorders | Peginterferon Alfa-2a 90 μg_48 Weeks | 29 | 132 | |
| other | Fatigue | General disorders | Peginterferon Alfa-2a 180 μg_48 Weeks | 32 | 130 | |
| other | Malaise | General disorders | Peginterferon Alfa-2a 90 μg_24 Weeks | 1 | 144 | |
| other | Malaise | General disorders | Peginterferon Alfa-2a 180 μg_24 Weeks | 9 | 141 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peginterferon Alfa-2a 90 μg_24 Weeks | ||
| Total, all-cause mortality | Peginterferon Alfa-2a 180 μg_24 Weeks | ||
| Total, all-cause mortality | Peginterferon Alfa-2a 90 μg_48 Weeks | ||
| Total, all-cause mortality | Peginterferon Alfa-2a 180 μg_48 Weeks | ||
| Total, other adverse events | Peginterferon Alfa-2a 90 μg_24 Weeks | 94 | 144 |
| Total, other adverse events | Peginterferon Alfa-2a 180 μg_24 Weeks | 109 | 141 |
| Total, other adverse events | Peginterferon Alfa-2a 90 μg_48 Weeks | 92 | 132 |
| Total, other adverse events | Peginterferon Alfa-2a 180 μg_48 Weeks | 105 | 130 |
| Total, serious adverse events | Peginterferon Alfa-2a 90 μg_24 Weeks | 4 | 144 |
| Total, serious adverse events | Peginterferon Alfa-2a 180 μg_24 Weeks | 4 | 141 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22045673 | 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 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.
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