Trial · NCT00922207
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
NCT00922207, Phase 4, Completed, Hoffmann-La Roche; results first posted 2015-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B. Trials, record NCT00922207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922207
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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 Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
- NCT number
- NCT00922207
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 280 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis B, Chronic
- Interventions
- Adefovir, Entecavir, Placebo, peginterferon alfa-2a [Pegasys]
- First posted
- 2009-06-17
- Last updated
- 2017-04-10
- Results first posted
- 2015-11-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment | Week 100 | HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe). |
| Secondary | Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication. |
| Secondary | Percentage of Participants Who Were HBeAg Negative | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | |
| Secondary | Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | |
| Secondary | Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels | Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100 | The normal range for ALT is 10 to 40 international units per liter (IU/L). |
| Secondary | Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | |
| Secondary | Percentage of Participants With Combined Response | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L). |
Source ClinicalTrials.gov
Outcomes7
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 e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment | Week 100 | ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | copies/mL | MEAN |
| SECONDARY | Percentage of Participants Who Were HBeAg Negative | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels | Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | International Units/milliliter (IU/mL) | MEAN |
| SECONDARY | Percentage of Participants With Combined Response | Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | ITT analysis population. Here, n = participants who had available assessment at specified time-point. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group204
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 e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment | Peg-IFN-Alfa-2a + Adefovir | 27.4 | 95% Confidence Interval 17.8 to 36.9 | percentage of participants | |
| Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment | Peg-IFN-Alfa-2a + Entecavir | 29.5 | 95% Confidence Interval 20.0 to 39.1 | percentage of participants | |
| Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment | Peg-IFN-Alfa-2a + Placebo | 36.3 | 95% Confidence Interval 26.4 to 46.1 | percentage of participants | |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Adefovir | Baseline (n=91,95,94) | 8.65 | Standard Deviation 1.03 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Entecavir | Baseline (n=91,95,94) | 8.30 | Standard Deviation 1.21 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Placebo | Baseline (n=91,95,94) | 8.41 | Standard Deviation 0.96 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Adefovir | Change at Week 4 (n=90,94,92) | -2.15 | Standard Deviation 0.94 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Entecavir | Change at Week 4 (n=90,94,92) | -2.76 | Standard Deviation 0.97 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Placebo | Change at Week 4 (n=90,94,92) | -0.23 | Standard Deviation 0.88 | copies/mL |
| Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 | Peg-IFN-Alfa-2a + Adefovir | Change at Week 8 (n=90,94,92) | -1.87 | Standard Deviation 1.40 | copies/mL |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peg-IFN-Alfa-2a + Adefovir | 91 | |
| Overall Study | STARTED | Peg-IFN-Alfa-2a + Entecavir | 95 | |
| Overall Study | STARTED | Peg-IFN-Alfa-2a + Placebo | 94 | |
| Overall Study | COMPLETED | Peg-IFN-Alfa-2a + Adefovir | 85 | |
| Overall Study | COMPLETED | Peg-IFN-Alfa-2a + Entecavir | 88 | |
| Overall Study | COMPLETED | Peg-IFN-Alfa-2a + Placebo | 90 | |
| Overall Study | NOT COMPLETED | Peg-IFN-Alfa-2a + Adefovir | 6 | |
| Overall Study | NOT COMPLETED | Peg-IFN-Alfa-2a + Entecavir | 7 | |
| Overall Study | NOT COMPLETED | Peg-IFN-Alfa-2a + Placebo | 4 |
Source ClinicalTrials.gov
Adverse events168
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 | Chills | General disorders | Peg-IFN-Alfa-2a + Adefovir | 6 | 91 | |
| other | Chills | General disorders | Peg-IFN-Alfa-2a + Entecavir | 0 | 94 | |
| other | Chills | General disorders | Peg-IFN-Alfa-2a + Placebo | 4 | 93 | |
| other | Fatigue | General disorders | Peg-IFN-Alfa-2a + Adefovir | 13 | 91 | |
| other | Fatigue | General disorders | Peg-IFN-Alfa-2a + Entecavir | 12 | 94 | |
| other | Fatigue | General disorders | Peg-IFN-Alfa-2a + Placebo | 15 | 93 | |
| other | Influenza like illnes | General disorders | Peg-IFN-Alfa-2a + Adefovir | 3 | 91 | |
| other | Influenza like illnes | General disorders | Peg-IFN-Alfa-2a + Entecavir | 5 | 94 | |
| other | Influenza like illnes | General disorders | Peg-IFN-Alfa-2a + Placebo | 3 | 93 | |
| other | Injection site pain | General disorders | Peg-IFN-Alfa-2a + Adefovir | 4 | 91 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peg-IFN-Alfa-2a + Adefovir | ||
| Total, all-cause mortality | Peg-IFN-Alfa-2a + Entecavir | ||
| Total, all-cause mortality | Peg-IFN-Alfa-2a + Placebo | ||
| Total, other adverse events | Peg-IFN-Alfa-2a + Adefovir | 85 | 91 |
| Total, other adverse events | Peg-IFN-Alfa-2a + Entecavir | 83 | 94 |
| Total, other adverse events | Peg-IFN-Alfa-2a + Placebo | 89 | 93 |
| Total, serious adverse events | Peg-IFN-Alfa-2a + Adefovir | 7 | 91 |
| Total, serious adverse events | Peg-IFN-Alfa-2a + Entecavir | 12 | 94 |
| Total, serious adverse events | Peg-IFN-Alfa-2a + Placebo | 7 | 93 |
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.
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/NCT00922207
GET https://conductscience.org/api/trials/v1/NCT00922207/results?page=2