Trial · NCT00536263
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
NCT00536263, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327). Trials, record NCT00536263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00536263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
- NCT number
- NCT00536263
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 671 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis B, Chronic
- Interventions
- pegylated interferon alpha-2b, pegylated interferon alpha-2b, pegylated interferon alpha-2b
- First posted
- 2007-09-27
- Last updated
- 2017-04-07
- Results first posted
- 2010-12-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 24 weeks after end of treatment (EOT) | HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA) |
| Secondary | Number of Participants With HBeAg Loss | Up to Treatment Week 48 | HBeAg Loss was tested by assay of Abbott MEIA |
| Secondary | HBe Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA. |
| Secondary | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Secondary | Number of Participants With HBV-DNA < 200 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Secondary | Number of Participants With HBV-DNA Undetectable | End of treatment (EOT) and 24 weeks after EOT | Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR). |
| Secondary | Number of Participants With Biochemical Response | End of treatment (EOT) and 24 weeks after EOT | Biochemical response was defined as alanine aminotransferase (ALT) normalization. |
| Secondary | Number of Participants With Combined Response | End of treatment (EOT) and 24 weeks after EOT | Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization |
| Secondary | Hepatitis B Surface Antigen (HBsAg) Loss | End of treatment (EOT) and 24 weeks after EOT | HBsAg Loss was tested by assay of Abbott MEIA |
| Secondary | Hepatitis B Surface Antigen (HBs) Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 24 weeks after end of treatment (EOT) | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With HBeAg Loss | Up to Treatment Week 48 | Treated participants | Participants | NUMBER |
| SECONDARY | HBe Seroconversion | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With HBV-DNA < 200 IU/mL | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With HBV-DNA Undetectable | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Biochemical Response | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Combined Response | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Hepatitis B Surface Antigen (HBsAg) Loss | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
| SECONDARY | Hepatitis B Surface Antigen (HBs) Seroconversion | End of treatment (EOT) and 24 weeks after EOT | Treated participants | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | 39 | Participants | ||
| Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | PEG 1.5 mcg/kg QW * 24 Weeks | 40 | Participants | ||
| Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | PEG 1.5 mcg/kg QW * 48 Weeks | 70 | Participants | ||
| Number of Participants With HBeAg Loss | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | 31 | Participants | ||
| Number of Participants With HBeAg Loss | PEG 1.5 mcg/kg QW * 24 Weeks | 28 | Participants | ||
| Number of Participants With HBeAg Loss | PEG 1.5 mcg/kg QW * 48 Weeks | 43 | Participants | ||
| HBe Seroconversion | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | EOT | 31 | Participants | |
| HBe Seroconversion | PEG 1.5 mcg/kg QW * 24 Weeks | EOT | 27 | Participants | |
| HBe Seroconversion | PEG 1.5 mcg/kg QW * 48 Weeks | EOT | 40 | Participants | |
| HBe Seroconversion | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | 24 weeks after EOT | 38 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 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 1.0 mcg/kg Weekly (QW) * 24 Weeks | 225 | |
| Overall Study | STARTED | PEG 1.5 mcg/kg QW * 24 Weeks | 221 | |
| Overall Study | STARTED | PEG 1.5 mcg/kg QW * 48 Weeks | 225 | |
| Overall Study | COMPLETED | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | 214 | |
| Overall Study | COMPLETED | PEG 1.5 mcg/kg QW * 24 Weeks | 207 | |
| Overall Study | COMPLETED | PEG 1.5 mcg/kg QW * 48 Weeks | 204 | |
| Overall Study | NOT COMPLETED | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | 11 | |
| Overall Study | NOT COMPLETED | PEG 1.5 mcg/kg QW * 24 Weeks | 14 | |
| Overall Study | NOT COMPLETED | PEG 1.5 mcg/kg QW * 48 Weeks | 21 |
Source ClinicalTrials.gov
Adverse events132
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 | ASTHENIA | General disorders | PEG 1.0 mcg/kg QW x24 Weeks | 12 | 225 | 15 |
| other | ASTHENIA | General disorders | PEG 1.5 mcg/kg QW x24 Weeks | 25 | 221 | 40 |
| other | ASTHENIA | General disorders | PEG 1.5 mcg/kg QW x48 Weeks | 15 | 224 | 21 |
| other | FATIGUE | General disorders | PEG 1.0 mcg/kg QW x24 Weeks | 35 | 225 | 106 |
| other | FATIGUE | General disorders | PEG 1.5 mcg/kg QW x24 Weeks | 29 | 221 | 119 |
| other | FATIGUE | General disorders | PEG 1.5 mcg/kg QW x48 Weeks | 42 | 224 | 153 |
| other | PYREXIA | General disorders | PEG 1.0 mcg/kg QW x24 Weeks | 156 | 225 | 253 |
| other | PYREXIA | General disorders | PEG 1.5 mcg/kg QW x24 Weeks | 158 | 221 | 316 |
| other | PYREXIA | General disorders | PEG 1.5 mcg/kg QW x48 Weeks | 168 | 224 | 444 |
| other | WEIGHT DECREASED | Investigations | PEG 1.0 mcg/kg QW x24 Weeks | 5 | 225 | 5 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG 1.0 mcg/kg QW x24 Weeks | ||
| Total, all-cause mortality | PEG 1.5 mcg/kg QW x24 Weeks | ||
| Total, all-cause mortality | PEG 1.5 mcg/kg QW x48 Weeks | ||
| Total, other adverse events | PEG 1.0 mcg/kg QW x24 Weeks | 173 | 225 |
| Total, other adverse events | PEG 1.5 mcg/kg QW x24 Weeks | 169 | 221 |
| Total, other adverse events | PEG 1.5 mcg/kg QW x48 Weeks | 182 | 224 |
| Total, serious adverse events | PEG 1.0 mcg/kg QW x24 Weeks | 10 | 225 |
| Total, serious adverse events | PEG 1.5 mcg/kg QW x24 Weeks | 11 | 221 |
| Total, serious adverse events | PEG 1.5 mcg/kg QW x48 Weeks | 15 | 224 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25200354 | RESULT |
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.
GET https://conductscience.org/api/trials/v1/NCT00536263
GET https://conductscience.org/api/trials/v1/NCT00536263/results?page=2