NCT06122285

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

October 30, 2023

Last Update Submit

January 8, 2025

Conditions

Hepatitis D

Outcome Measures

Primary Outcomes (2)

  • Describe the virological response to BLV in all patients starting BLV therapy for CHD

    Percentage of patients with undetectable HDV RNA

    Month 6

  • Describe the virological response to BLV in all patients starting BLV therapy for CHD

    Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA

    Month 12

Secondary Outcomes (22)

  • Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

    Month 6

  • Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

    Month 12

  • Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA

    Month 6

  • Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA

    Month 12

  • Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT

    Month 6

  • +17 more secondary outcomes

Study Arms (1)

Hepatis Delta

Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously

Drug: Bulevirtide

Interventions

BulevirtideDRUG

dose of 2 mg/day subcutaneously

Hepatis Delta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with CHD (quantifiable HDV-RNA) who will start treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • HDV-related decompensated cirrhosis (CPT ≥7)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.

Milan, MI, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Hepatitis D

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 8, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 31, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

IT(1)