NCT06122285 Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
| NCT ID | NCT06122285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Hepatitis D |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2023-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-05-01 with a primary completion date of 2023-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a \>2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ \<6 IU/ml) at month 12 of therapy. HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older * Chronic hepatitis delta * Compensated cirrhosis HDV related * Patients who will start therapy with BLV 2 mg/day from May 2023 Exclusion Criteria: * HDV-related decompensated cirrhosis (CPT ≥7)
Frequently Asked Questions
Who can join the NCT06122285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06122285 currently recruiting?
Yes, NCT06122285 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico to inquire about joining.
Where is the NCT06122285 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06122285 clinical trial?
NCT06122285 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 100 participants.