Trial · NCT06397859
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
NCT06397859, Recruiting, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis. Trials, record NCT06397859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06397859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
- NCT number
- NCT06397859
- Status
- Recruiting
- Enrollment
- 266 participants, estimated
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Conditions
- Hepatitis D
- Interventions
- Bulevirtide
- First posted
- 2024-05-03
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigate the virological response rate to BLV | Week 96 | Percentage of patients with \>2 Log decline in HDV-RNA (IU/mL) |
| Primary | Investigate the virological response rate to BLV | Week 96 | Percentage of patients with undetectable HDV-RNA (IU/mL) |
| Secondary | Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response) | Week 96 | Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT (combined response) |
| Secondary | Evaluation of the percentage of patients with normal ALT | Week 96 | Percentage of patients with normal ALT |
| Secondary | Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA | Week 96 | Percentage of patients with \< 1 log decline HDV RNA levels |
| Secondary | Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment. | Week 96 | Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96; |
| Secondary | Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response | Week 96 | Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV |
| Secondary | Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available) | Year 5 | Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5 |
| Secondary | Evaluation of bile acids levels over time and correlation of bile levels with virological response rates | Week 96 | Correlation between bile acids levels and virological response over time |
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/NCT06397859
GET https://conductscience.org/api/trials/v1/NCT06397859/registered