Trial · NCT05494528
Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy
NCT05494528, Not applicable, Unknown, National Taiwan University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy. Trials, record NCT05494528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05494528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy
- NCT number
- NCT05494528
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 90 participants, estimated
- Lead sponsor
- National Taiwan University Hospital
- Conditions
- Chronic Hepatitis B Virus Infection
- Interventions
- Ropeginterferon alfa-2b, Entecavir
- First posted
- 2022-08-10
- Last updated
- 2022-12-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Undetectable HBsAg | Week 48 | HBsAg loss at week 48 |
| Secondary | Undetectable HBsAg | weeks 72 and 96 | HBsAg loss at weeks 72 and 96 |
| Secondary | HBsAg level | weeks 12, 24, 48, 72 and 96 | HBsAg reduction \> 1 log from baseline to weeks 12, 24, 48, 72 and 96 |
| Secondary | HBsAg and anti-HBs level | weeks 48, 72 and 96 | HBsAg seroconversion at weeks 48, 72 and 96 |
| Secondary | HBsAg level | weeks 12, 24, 48, 72, and 96 | Mean HBsAg decline from baseline to weeks 12, 24, 48, 72, and 96 |
| Secondary | Reappearance of HBsAg | weeks 72 and 96 | HBsAg seroreversion at weeks 72 and 96 |
| Secondary | HBV DNA level | week 96 | Percentage of subjects with HBV DNA \> 2,000 IU/ml at week 96 |
| Secondary | HBV DNA and alanine aminotransferase (ALT) level | week 96 | Percentage of subjects with HBV DNA \> 2,000 IU/ml and ALT \> 2x ULN at week 96 |
| Secondary | Sustained suppression of HBV DNA | week 96 | Sustained suppression of HBV DNA less than the lower limit of qualification at week 96. |
| Secondary | HBeAg level | weeks 72 and 96 | To compare the proportion of HBeAg seroreversion and seroconversion at weeks 72 and 96 across treatment arms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05494528
GET https://conductscience.org/api/trials/v1/NCT05494528/registered