Trial · NCT06504485
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | Correlate the prevalence of HDV-specific T cell responses with response to treatment over time | through study completion, an average of 2 year | Correlation between the change in HDV-specific T responses |
| Secondary | Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide; | through study completion, an average of 2 year | Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with response to treatment with Bulevirtide |
| Secondary | Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment | through study completion, an average of 2 year | Correlation between the quantification of HDV RNA within exosomes and the response to treatment with Bulevirtide |
| Secondary | Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide | through study completion, an average of 2 year | Correlation between HDV genetic heritage and response to treatment with Bulevirtide |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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