Trial · NCT00371761
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
NCT00371761, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278). Trials, record NCT00371761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00371761
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
- NCT number
- NCT00371761
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis B, Chronic (CHB)
- Interventions
- Pegylated interferon alfa-2b (PegIntron), Adefovir dipivoxil (adefovir)
- First posted
- 2006-09-04
- Last updated
- 2017-04-06
- Results first posted
- 2010-12-15
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response | At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks] | 1. Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive. 2. Virological response was defined as having \< 10\^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction). 3. Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L. |
Source ClinicalTrials.gov
Outcomes1
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 Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response | At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks] | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response | PegIntron | 0 | Participants | ||
| Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response | Adefovir | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PegIntron | 13 | |
| Overall Study | STARTED | Adefovir | 12 | |
| Overall Study | COMPLETED | PegIntron | 5 | |
| Overall Study | COMPLETED | Adefovir | 2 | |
| Overall Study | NOT COMPLETED | PegIntron | 8 | |
| Overall Study | NOT COMPLETED | Adefovir | 10 |
Source ClinicalTrials.gov
Adverse events102
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 | LEUKOPENIA | Blood and lymphatic system disorders | PegIntron | 5 | 13 | 9 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Adefovir | 0 | 12 | 0 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | PegIntron | 2 | 13 | 3 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Adefovir | 0 | 12 | 0 |
| other | PALPITATIONS | Cardiac disorders | PegIntron | 0 | 13 | 0 |
| other | PALPITATIONS | Cardiac disorders | Adefovir | 1 | 12 | 1 |
| other | VERTIGO | Ear and labyrinth disorders | PegIntron | 1 | 13 | 2 |
| other | VERTIGO | Ear and labyrinth disorders | Adefovir | 0 | 12 | 0 |
| other | CONJUNCTIVITIS | Eye disorders | PegIntron | 1 | 13 | 1 |
| other | CONJUNCTIVITIS | Eye disorders | Adefovir | 0 | 12 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PegIntron | ||
| Total, all-cause mortality | Adefovir | ||
| Total, other adverse events | PegIntron | 13 | 13 |
| Total, other adverse events | Adefovir | 8 | 12 |
| Total, serious adverse events | PegIntron | 1 | 13 |
| Total, serious adverse events | Adefovir | 0 | 12 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PegIntron vs Adefovir: Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response | Trial comparisons |
| PegIntron vs Adefovir: serious adverse events | Trial comparisons |
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/NCT00371761
GET https://conductscience.org/api/trials/v1/NCT00371761/events?page=2