Hepatitis D Clinical Trial
Official title:
Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02044055 -
Mother-to-child Hepatitis D Transmission
|
N/A | |
| Completed |
NCT02375906 -
The Hepatitis Delta International Network
|
||
| Not yet recruiting |
NCT05394623 -
Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)
|
||
| Recruiting |
NCT04863703 -
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
|
||
| Recruiting |
NCT06397859 -
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
|
||
| Recruiting |
NCT00001971 -
Evaluation of Patients With Liver Disease
|
||
| Recruiting |
NCT06264583 -
HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection
|
||
| Recruiting |
NCT06122285 -
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
|
||
| Recruiting |
NCT05928000 -
HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV
|
||
| Terminated |
NCT04847440 -
A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection
|
Phase 2 | |
| Recruiting |
NCT05936073 -
DELTA DESCRIBE: the French Collaborative Project
|
||
| Completed |
NCT00932971 -
HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis
|
Phase 2 | |
| Completed |
NCT06360484 -
Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus
|
||
| Completed |
NCT02511431 -
Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
|
Phase 2 | |
| Not yet recruiting |
NCT05451082 -
Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
|
||
| Recruiting |
NCT05903742 -
Standardising Care for Hepatitis Delta in the Netherlands
|
||
| Not yet recruiting |
NCT03362866 -
Epidemiology of Hepatitis B, C and Delta in Reunion Island
|
||
| Terminated |
NCT01316185 -
Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
|
Phase 1 | |
| Recruiting |
NCT05264272 -
Disease Loads and Status of Treatment
|
||
| Completed |
NCT05002907 -
Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)
|