Trial · NCT01326546
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
NCT01326546, Phase 2, Completed, Chongqing Jiachen Biotechnology Ltd.; results first posted 2019-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients. Trials, record NCT01326546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01326546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
- NCT number
- NCT01326546
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Chongqing Jiachen Biotechnology Ltd.
- Conditions
- Chronic Hepatitis B
- Interventions
- Therapeutic HBV vaccine, entecavir, placebo
- First posted
- 2011-03-31
- Last updated
- 2019-06-26
- Results first posted
- 2019-06-26
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 Participants With HBeAg Seroconversion at Week 48 | 48 weeks | Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF) |
| Secondary | Serological Response | 96 weeks | Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg. |
| Secondary | Virological Response | 96 weeks | Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level \<1.72×104 IU/ml. |
| Secondary | Biochemistry Response | 96 weeks | Biochemistry response at every observation time, mean the ALT level reduce to normal. |
| Secondary | Histological Response | 72 weeks | Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment. |
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 Participants With HBeAg Seroconversion at Week 48 | 48 weeks | Intention-To-Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serological Response | 96 weeks | |||
| SECONDARY | Virological Response | 96 weeks | |||
| SECONDARY | Biochemistry Response | 96 weeks | |||
| SECONDARY | Histological Response | 72 weeks |
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 |
|---|---|---|---|---|---|
| Percentage of Participants With HBeAg Seroconversion at Week 48 | Therapeutic HBV Vaccine+Entecavir | 21 | Participants | ||
| Percentage of Participants With HBeAg Seroconversion at Week 48 | Placebo+Entecavir | 23 | 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 | Therapeutic HBV Vaccine+Entecavir | 189 | |
| Overall Study | STARTED | Placebo+Entecavir | 189 | |
| Overall Study | COMPLETED | Therapeutic HBV Vaccine+Entecavir | 172 | |
| Overall Study | COMPLETED | Placebo+Entecavir | 176 | |
| Overall Study | NOT COMPLETED | Therapeutic HBV Vaccine+Entecavir | 17 | |
| Overall Study | NOT COMPLETED | Placebo+Entecavir | 13 |
Source ClinicalTrials.gov
Adverse events12
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 | upper respiratory infection | Infections and infestations | Therapeutic HBV Vaccine+Entecavir | 10 | 189 | |
| other | upper respiratory infection | Infections and infestations | Placebo+Entecavir | 10 | 189 | |
| other | nasopharyngitis | Infections and infestations | Therapeutic HBV Vaccine+Entecavir | 21 | 189 | |
| other | nasopharyngitis | Infections and infestations | Placebo+Entecavir | 24 | 189 | |
| other | Diarrhea | Gastrointestinal disorders | Therapeutic HBV Vaccine+Entecavir | 2 | 189 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo+Entecavir | 8 | 189 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Therapeutic HBV Vaccine+Entecavir | 7 | 189 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo+Entecavir | 6 | 189 | |
| other | Dizziness | Nervous system disorders | Therapeutic HBV Vaccine+Entecavir | 4 | 189 | |
| other | Dizziness | Nervous system disorders | Placebo+Entecavir | 6 | 189 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Therapeutic HBV Vaccine+Entecavir | 0 | 189 |
| Total, all-cause mortality | Placebo+Entecavir | 0 | 189 |
| Total, other adverse events | Therapeutic HBV Vaccine+Entecavir | 38 | 189 |
| Total, other adverse events | Placebo+Entecavir | 54 | 189 |
| Total, serious adverse events | Therapeutic HBV Vaccine+Entecavir | 1 | 189 |
| Total, serious adverse events | Placebo+Entecavir | 0 | 189 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Therapeutic HBV Vaccine+Entecavir vs Placebo+Entecavir: Percentage of Participants With HBeAg Seroconversion at Week 48 | Trial comparisons |
| Therapeutic HBV Vaccine+Entecavir vs Placebo+Entecavir: deaths from any cause | Trial comparisons |
| Therapeutic HBV Vaccine+Entecavir vs Placebo+Entecavir: 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/NCT01326546
GET https://conductscience.org/api/trials/v1/NCT01326546/registered