Trial · NCT06504485
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
NCT06504485, Completed, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment. Trials, record NCT06504485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06504485
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
- NCT number
- NCT06504485
- Status
- Completed
- Enrollment
- 192 participants, actual
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Conditions
- Hepatitis D
- Interventions
- Bulevirtide
- First posted
- 2024-07-16
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide | through study completion, an average of 2 year | Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide |
| Primary | Change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment) | Month 12 | Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection after 12 months of treatment with Bulevirtide compared to baseline (pre-therapy) |
| Secondary | Correlate HDV-specific T cell response with stage of liver disease | through study completion, an average of 2 year | Correlation of HDV-specific T cell response with stage of liver disease |
| Secondary | Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease | through study completion, an average of 2 year | Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with the stage of liver disease |
| Secondary | Correlate the quantification of HDV RNA within exosomes with the stage of liver disease | through study completion, an average of 2 year | Correlation between the quantification of HDV RNA within exosomes and the disease phenotype |
| Secondary | Investigate the correlation between the genetic heritage of HDV and the stage of liver disease | through study completion, an average of 2 year | Correlation between the genetic heritage of HDV and the stage of liver disease |
| Secondary | Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection | through study completion, an average of 2 year | Transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection |
| Secondary | Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance | through study completion, an average of 2 year | Correlation between HDV mutations and the ability of the virus itself to escape CD8 T cell surveillance |
| Secondary | Correlate the prevalence of HDV-specific T cell responses with response to treatment over time | Month 6 | Correlation between the change in HDV-specific T responses |
| Secondary | Correlate the prevalence of HDV-specific T cell responses with response to treatment over time | Month 18 | Correlation between the change in HDV-specific T responses |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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/NCT06504485
GET https://conductscience.org/api/trials/v1/NCT06504485/registered