NCT05962307

Brief Summary

Spontaneous, pharmacological observational, no-profit, retrospective, multi-center. 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 retrospectively/longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, 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. All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

March 1, 2023

Enrollment Period

29 days

First QC Date

March 21, 2023

Last Update Submit

July 24, 2023

Conditions

Hepatitis D

Outcome Measures

Primary Outcomes (2)

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

    percentage of patients with undetectable HDV RNA.

    Month 12

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

    percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.

    Month 12

Secondary Outcomes (4)

  • Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment

    Month 12

  • Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment

    Month 12

  • Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at the end of the first year of treatment

    Month 12

  • Evaluation of treatment safety

    Month 12

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 active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated 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
  • Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022

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

Location

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

July 27, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-03

Locations

IT(1)