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Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

NCT06603311 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-09-30
Last updated
2026-03-03

Condition(s) studied

Compensated Liver Disease (Disorder)Hepatitis D, Chronic

Investigational drug(s) / intervention(s)

Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection

Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection: Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection who have been treated for at least 48 weeks and reached HDV RNA below 100 IU/ml for at least 24 weeks.

Study summary

Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Men, women, inter/diverse\* aged ≥ 18 years 2. Signed written informed consent from subject 3. Chronic hepatitis delta 4. Stable and continued NUC treatment of the underlying HBV infection 5. Previous interferon treatment must have stopped at least 6 months before the start of BLV monotherapy 6. Previous immunosuppressant therapy must have stopped at least 6 months before the start of BLV therapy 7. BLV treatment for at least 48 weeks 8. HDV-RNA below 100 IU/ml under BLV treatment for at least 24 weeks. Patients should have had at least 2 tests with HDV-RNA below 100 IU/ml plus one test with HDV-RNA below 100 IU/ml+ at screening. 9. ALT level below 1.5 fold ULN Exclusion Criteria: 1. Patients with decompensated liver cirrhosis (transient mild deviations in liver function parameters are acceptable at the discretion of the investigator) or history of decompensated liver cirrhosis (patients with minimal perihepatic ascites could be included at the discretion of the investigator) 2. Hepatocellular carcinoma (HCC) 3. Thrombocytopenia (platelet count below 90.000/µl) 4. Participation in another interventional clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment) 5. Any additional medical reason not to stop BLV

Primary outcome measure(s)

  • Area under the curve (AUC) of biomarker on HDV-RNA relapse at week 48 — week 48
    All primary analysis will be carried out in the FAS. All patients will be categorized into two subgroups based on HDV-RNA relapse (yes/no) at week 48: 1. HDV-RNA relapse: HDV-RNA ≥ 1000 IU/ml at any time point up to week 48 2. No HDV-RNA relapse: HDV-RNA above 1000 IU/ml at all time points up to week 48 For the primary analysis, patients with missing HDV-RNA relapse outcome will be imputed with HDV-RNA relapse. Patients who re-initiated bulevirtide will be analysed as having a HDV-RNA relapse independent of their actual relapse status.

Trial sites (5)

FacilityCityRegionStatus
University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning Heidelberg Baden-Wurttemberg
University Hospital Frankfurt; Medical Clinic 1 Frankfurt am Main Hesse
Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology Hanover Lower Saxony
Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology Berlin State of Berlin
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Division of Gastroenterology and Hepatology Milan Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06603311 on ClinicalTrials.gov ↗ ← All trials in Italy