Trial · NCT01641926
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
NCT01641926, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2017-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450). Trials, record NCT01641926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01641926
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
- NCT number
- NCT01641926
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 402 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis B, Chronic
- Interventions
- PEG-Intron™, PEGASYS™
- First posted
- 2012-07-17
- Last updated
- 2018-08-27
- Results first posted
- 2017-01-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. |
| Primary | Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported. |
| Secondary | Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported. |
| Secondary | Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported. |
| Secondary | Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels \<2000 IU/mL at 24 weeks post-treatment was reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion. | percentage of participants | NUMBER |
| PRIMARY | Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | FU Week 24 (Study Week 72) | All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment | HBeAg(+) PEG-Intron | 25.4 | percentage of participants | ||
| Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment | HBeAg(+) PEGASYS | 23.6 | percentage of participants | ||
| Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment | HBeAg(-) PEG-Intron | 30.4 | percentage of participants | ||
| Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment | HBeAg(-) PEGASYS | 33.3 | percentage of participants | ||
| Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | HBeAg(+) PEG-Intron | 23.9 | percentage of participants | ||
| Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment | HBeAg(+) PEGASYS | 21.5 | percentage of participants | ||
| Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | HBeAg(+) PEG-Intron | 49.3 | percentage of participants | ||
| Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | HBeAg(+) PEGASYS | 47.2 | percentage of participants | ||
| Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | HBeAg(-) PEG-Intron | 71.4 | percentage of participants | ||
| Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment | HBeAg(-) PEGASYS | 61.4 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HBeAg(+) PEG-Intron | 143 | |
| Overall Study | STARTED | HBeAg(+) PEGASYS | 145 | |
| Overall Study | STARTED | HBeAg(-) PEG-Intron | 57 | |
| Overall Study | STARTED | HBeAg(-) PEGASYS | 57 | |
| Overall Study | Treated (All Participants as Treated) | HBeAg(+) PEG-Intron | 142 | |
| Overall Study | Treated (All Participants as Treated) | HBeAg(+) PEGASYS | 144 | |
| Overall Study | Treated (All Participants as Treated) | HBeAg(-) PEG-Intron | 56 | |
| Overall Study | Treated (All Participants as Treated) | HBeAg(-) PEGASYS | 57 | |
| Overall Study | COMPLETED | HBeAg(+) PEG-Intron | 115 | |
| Overall Study | COMPLETED | HBeAg(+) PEGASYS | 130 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events264
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 | HBeAg(+) PEG-Intron | 12 | 142 | 18 |
| other | Neutropenia | Blood and lymphatic system disorders | HBeAg(+) PEGASYS | 13 | 144 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | HBeAg(-) PEG-Intron | 5 | 56 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | HBeAG(-) PEGASYS | 2 | 57 | 3 |
| other | Vision blurred | Eye disorders | HBeAg(+) PEG-Intron | 2 | 142 | 2 |
| other | Vision blurred | Eye disorders | HBeAg(+) PEGASYS | 3 | 144 | 3 |
| other | Vision blurred | Eye disorders | HBeAg(-) PEG-Intron | 0 | 56 | 0 |
| other | Vision blurred | Eye disorders | HBeAG(-) PEGASYS | 3 | 57 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | HBeAg(+) PEG-Intron | 11 | 142 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | HBeAg(+) PEGASYS | 8 | 144 | 19 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HBeAg(+) PEG-Intron | ||
| Total, all-cause mortality | HBeAg(+) PEGASYS | ||
| Total, all-cause mortality | HBeAg(-) PEG-Intron | ||
| Total, all-cause mortality | HBeAG(-) PEGASYS | ||
| Total, other adverse events | HBeAg(+) PEG-Intron | 126 | 142 |
| Total, other adverse events | HBeAg(+) PEGASYS | 124 | 144 |
| Total, other adverse events | HBeAg(-) PEG-Intron | 50 | 56 |
| Total, other adverse events | HBeAG(-) PEGASYS | 50 | 57 |
| Total, serious adverse events | HBeAg(+) PEG-Intron | 12 | 142 |
| Total, serious adverse events | HBeAg(+) PEGASYS | 10 | 144 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01641926
GET https://conductscience.org/api/trials/v1/NCT01641926/events?page=2