Active — Not RecruitingNot Applicable

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

Germany, Italy20 participantsStarted 2024-09-30

Plain-language summary

Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men, women, inter/diverse\* aged ≥ 18 years
✓. Signed written informed consent from subject
✓. Chronic hepatitis delta
✓. Stable and continued NUC treatment of the underlying HBV infection
✓. Previous interferon treatment must have stopped at least 6 months before the start of BLV monotherapy
✓. Previous immunosuppressant therapy must have stopped at least 6 months before the start of BLV therapy
✓. BLV treatment for at least 48 weeks
✓. 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.

✕. 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)
✕. Hepatocellular carcinoma (HCC)
✕. Thrombocytopenia (platelet count below 90.000/µl)
✕. Participation in another interventional clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
✕. Any additional medical reason not to stop BLV

Area under the curve (AUC) of biomarker on HDV-RNA relapse at week 48

Timeframe: week 48

NCT IDNCT06603311

SponsorHannover Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men, women, inter/diverse\* aged ≥ 18 years
✓. Signed written informed consent from subject
✓. Chronic hepatitis delta
✓. Stable and continued NUC treatment of the underlying HBV infection
✓. Previous interferon treatment must have stopped at least 6 months before the start of BLV monotherapy
✓. Previous immunosuppressant therapy must have stopped at least 6 months before the start of BLV therapy
✓. BLV treatment for at least 48 weeks
✓. 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.

✕. 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)
✕. Hepatocellular carcinoma (HCC)
✕. Thrombocytopenia (platelet count below 90.000/µl)
✕. Participation in another interventional clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
✕. Any additional medical reason not to stop BLV