Trial · NCT00686790
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
NCT00686790, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603). Trials, record NCT00686790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00686790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
- NCT number
- NCT00686790
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis D, Chronic, Hepatitis B, Chronic
- Interventions
- Peginterferon alfa-2b (PegIntron, SCH 54031)
- First posted
- 2008-05-30
- Last updated
- 2017-04-06
- Results first posted
- 2011-01-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Virological Response | 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation | For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT). |
| Primary | Number of Participants With a Biochemical Response | 52 weeks (EOT), 104 weeks (EOF) | A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L. |
| Primary | Number of Participants With a Combined Response | 52 weeks (EOT), 104 weeks (EOF) | The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L. |
| Secondary | Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | 52 week (EOT) | Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum. |
| Secondary | Number of Participants With a Liver Histology Response | Baseline and 52 week (EOT) | The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis \[0-10\], lobular inflammation \[0-4\], portal inflammation \[0-4\], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored \[0-4\]) in the pre- and post-treatment liver biopsies. The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT. |
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 | Number of Participants With a Virological Response | 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | 52 week (EOT) | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Biochemical Response | 52 weeks (EOT), 104 weeks (EOF) | The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Combined Response | 52 weeks (EOT), 104 weeks (EOF) | The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Liver Histology Response | Baseline and 52 week (EOT) | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group19
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 a Virological Response | PegIntron | Responders at 52 weeks | 12 | Participants | |
| Number of Participants With a Virological Response | PegIntron | Non-responders at 52 weeks | 24 | Participants | |
| Number of Participants With a Virological Response | PegIntron | Responders at 104 weeks | 9 | Participants | |
| Number of Participants With a Virological Response | PegIntron | Non-responders at 104 weeks | 27 | Participants | |
| Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | PegIntron | Responders | 6 | Participants | |
| Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | PegIntron | Non responders | 30 | Participants | |
| Number of Participants With a Biochemical Response | PegIntron | Responders at 52 weeks | 18 | Participants | |
| Number of Participants With a Biochemical Response | PegIntron | Non-responders at 52 weeks | 14 | Participants | |
| Number of Participants With a Biochemical Response | PegIntron | Responders at 104 weeks | 9 | Participants | |
| Number of Participants With a Biochemical Response | PegIntron | Non-responders at 104 weeks | 23 | Participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PegIntron | 48 | |
| Overall Study | COMPLETED | PegIntron | 32 | |
| Overall Study | NOT COMPLETED | PegIntron | 16 |
Source ClinicalTrials.gov
Adverse events37
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 | VERTIGO | Ear and labyrinth disorders | PegIntron | 9 | 49 | 86 |
| other | VISION BLURRED | Eye disorders | PegIntron | 3 | 49 | 15 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | PegIntron | 9 | 49 | 32 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | PegIntron | 3 | 49 | 3 |
| other | DIARRHOEA | Gastrointestinal disorders | PegIntron | 5 | 49 | 7 |
| other | DRY MOUTH | Gastrointestinal disorders | PegIntron | 3 | 49 | 11 |
| other | GINGIVAL BLEEDING | Gastrointestinal disorders | PegIntron | 4 | 49 | 8 |
| other | NAUSEA | Gastrointestinal disorders | PegIntron | 18 | 49 | 94 |
| other | VOMITING | Gastrointestinal disorders | PegIntron | 7 | 49 | 20 |
| other | ASTHENIA | General disorders | PegIntron | 16 | 49 | 76 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PegIntron | ||
| Total, other adverse events | PegIntron | 47 | 49 |
| Total, serious adverse events | PegIntron | 3 | 49 |
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/NCT00686790
GET https://conductscience.org/api/trials/v1/NCT00686790/events?page=2