Trial · NCT05467553
A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection
NCT05467553, Phase 2, Unknown, National Taiwan University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection. Trials, record NCT05467553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05467553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection
- NCT number
- NCT05467553
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- National Taiwan University Hospital
- Conditions
- Hepatitis D
- Interventions
- Ursodeoxycholic acid, Ropeginterferon alfa-2b, Tenofovir Alafenamide
- First posted
- 2022-07-20
- Last updated
- 2022-12-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HDV RNA level | Week 60 | Decline in HDV RNA ≥ 2 log10 IU/mL at Week 60 |
| Primary | ALT level | Week 60 | ALT normalization (ALT \< upper limit of normal) at Week 60 |
| Secondary | Undetectable HDV RNA | Week 60 and Week 84 | Undetectable HDV RNA (HDV RNA\< low limit of quantifica-tion) at Week 60 and Week 84 |
| Secondary | HBsAg level | Week 60 and Week 84 | Reduction in HBsAg ≥ 1 log10 IU/mL at Week 60 and Week 84 |
| Secondary | Undetectable HBsAg | Week 60 and Week 84 | HBsAg loss at Week 60 and Week 84 |
| Secondary | HBsAg and anti-HBs level | Week 60 and Week 84 | HBsAg seroconversion (HBsAg loss plus positive anti-HBs) at Week 60 and Week 84 |
| Secondary | HDV RNA level | Week 84 | Decline in HDV RNA ≥ 2 log10 IU/mL at Week 84 |
| Secondary | ALT level | Week 84 | ALT normalization (ALT \< upper limit of normal) at Week 84 |
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/NCT05467553
GET https://conductscience.org/api/trials/v1/NCT05467553/registered