Trial · NCT06051045
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
NCT06051045, Recruiting, Karolinska University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients. Trials, record NCT06051045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06051045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
- NCT number
- NCT06051045
- Status
- Recruiting
- Enrollment
- 400 participants, estimated
- Lead sponsor
- Karolinska University Hospital
- Conditions
- Chronic Hepatitis D
- Interventions
- Bulevirtide
- First posted
- 2023-09-22
- Last updated
- 2023-09-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with virological response of Hepatitis D virus (HDV) RNA < Limit of Detection (LoD) at FU 12 months after End of Treatment (EOT). | Continuously, up to 12 months | Measurement of virological response of HDV RNA \< LoD |
| Secondary | Percentage of patients with virological response of HDV RNA < LoD | At Baseline, 1 and 3 months, every 3 months after treatment start up to 9 months after date of EOT. | Percentage of patients with virological response of HDV RNA \< LoD at at month 1, 3 and every 3 months after treatment start, and FU month 3, 6, and 9 after EOT. |
| Secondary | Percentage of patients with Hepatitis B surface antigen (HBsAg) < LoD | At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT. | Percentage of patients with HBsAg \< LoD at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Change of HBsAg from baseline | From Baseline every 3 months until end of study. | Change of HBsAg from baseline every 3 months during study period. |
| Secondary | Percentage of patients with HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline | At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT. | Percentage of patients with HDV RNA \< LoD or HDV RNA reduction of at least 2 log10 compared to baseline, at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with virological relapse, defined as HDV RNA < LoD at EOT and increase of HDV RNA to > LoD after EOT | At 0, 3, 6, 9 and 12 months after date of EOT. | Percentage of patients with virological relapse, defined as HDV RNA \< LoD at EOT and increase of HDV RNA to \> LoD after EOT, after EOT, at FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with appearance of hepatitis B surface antibody (anti-HBs) | At 0, 3, 6, 9 and 12 months after date of EOT. | Percentage of patients with appearance of hepatitis B surface antibody (anti-HBs) at EOT, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with HBV DNA level < LoD | From Baseline every 3 months until end of study. | Percentage of patients with HBV DNA level \< LoD every 3 months during study period. |
| Secondary | Percentage of patients with biochemical response, defined as normalization of alanine transaminase (ALT) | At Baseline, 1 and 3 months, every 3 months up to 12 months after date of EOT. | Percentage of patients with biochemical response, defined as normalization of alanine transaminase (ALT), at month 1, 3 and every 3 months during treatment, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with combined response, defined as HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline and Alanine Aminotransferase (ALT) normalization | At Baseline, at 1, 2 and 3 months, every 3 months up to 12 months after date of EOT. | Percentage of patients with combined response, defined as HDV RNA \< LoD or HDV RNA reduction of at least 2 log10 compared to baseline and ALT normalization, at month 1, 2 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
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/NCT06051045
GET https://conductscience.org/api/trials/v1/NCT06051045/registered