HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV

NCT05928000 | Unknown FDA Drug

• 1 other identifier: UAthens-HERACLIS-BLV
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficacy and safety of bulevirtide (BLV) in chronic hepatitis D patients treated in Greek liver centers.

Conditions

Hepatitis D

Keywords

bulevirtide; NTCP inhibitor; Hepatitis D

Outcome Measures

Primary Outcomes (1)

• Response at week 48

  Proportion of patients with serum HDV RNA decline \>=2 log10 IU/ml and normal ALT

  Week 48

Secondary Outcomes (3)

• Response at week 96

  Week 96

• Complete response at week 48

  Week 48

• Complete response at week 96

  Week 96

Study Arms (1)

BLV-treated patients

All patients treated with daily Bulevirtide (BLV) subcutaneous injections of 2 mg, with or without concomitant use of a nucleos(t)ide analogue. Patients with concomitant use of pegylated interferon-alfa can be included.

Drug: Bulevirtide

Interventions

Bulevirtide DRUG

BulevIrtide treatment in patients with chronic hepatitis D

Also known as: Entecavir, Tenofovir, Pegasys

BLV-treated patients

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include all adult (\>16 years old) patients with chronic hepatitis D followed at any of the participating centers who started BLV before the approval of the study protocol. Thus, the decision to use BLV will not be affected by the patient enrollment in the study,

You may qualify if:

• All adult (\>16 years old) patients with chronic hepatitis D followed at any of the participating centers
• Start of BLV treatment before the approval of the study protocol.
• Any patient with or without concomitant use of a nucleos(t)ide analogue. Patients with concomitant use of pegylated interferon-alfa can be included.

You may not qualify if:

• Any patient with chronic hepatitis D who started BLV after the start of the study protocol

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Department of Gastroenterology, Medical School of National & Kapodistrian University of Athens, General Hospital of Athens "Laiko";

Athens, 11527, Greece

RECRUITING

Related Publications (6)

• Papatheodoridi M, Papatheodoridis GV. Is hepatitis delta underestimated? Liver Int. 2021 Jun;41 Suppl 1:38-44. doi: 10.1111/liv.14833.

  PMID: 34155795 RESULT

• Wedemeyer H. The burden of hepatitis D - defogging the epidemiological horizon. J Hepatol. 2020 Sep;73(3):493-495. doi: 10.1016/j.jhep.2020.06.037. Epub 2020 Jul 16. No abstract available.

  PMID: 32684365 RESULT

• Papatheodoridis G, Mimidis K, Manolakopoulos S, Triantos C, Vlachogiannakos I, Veretanos C, Deutsch M, Karatapanis S, Goulis I, Elefsiniotis I, Cholongitas E, Sevastianos V, Christodoulou D, Samonakis D, Manesis E, Kapatais A, Papadopoulos N, Ioannidou P, Germanidis G, Giannoulis G, Lakiotaki D, Kogias D, Kranidioti Eta, Zisimopoulos K, Mela M, Kontos G, Fytili P, Manolaka C, Agorastou P, Pantzios SI, Papatheodoridi M, Karagiannakis D, Geladari E, Psychos N, Zachou K, Chalkidou A, Spanoudaki A, Thomopoulos K, Dalekos G. HERACLIS-HDV cohort for the factors of underdiagnosis and prevalence of hepatitis D virus infection in HBsAg-positive patients. Liver Int. 2023 Sep;43(9):1879-1889. doi: 10.1111/liv.15638. Epub 2023 Jun 8.

  PMID: 37288712 RESULT

• Papatheodoridi M, Papatheodoridis GV. Current status of hepatitis delta. Curr Opin Pharmacol. 2021 Jun;58:62-67. doi: 10.1016/j.coph.2021.03.008. Epub 2021 Apr 22.

  PMID: 33895531 RESULT

• Bogomolov P, Alexandrov A, Voronkova N, Macievich M, Kokina K, Petrachenkova M, Lehr T, Lempp FA, Wedemeyer H, Haag M, Schwab M, Haefeli WE, Blank A, Urban S. Treatment of chronic hepatitis D with the entry inhibitor myrcludex B: First results of a phase Ib/IIa study. J Hepatol. 2016 Sep;65(3):490-8. doi: 10.1016/j.jhep.2016.04.016. Epub 2016 Apr 27.

  PMID: 27132170 RESULT

• Wedemeyer H, Aleman S, Brunetto MR, Blank A, Andreone P, Bogomolov P, Chulanov V, Mamonova N, Geyvandova N, Morozov V, Sagalova O, Stepanova T, Berger A, Manuilov D, Suri V, An Q, Da B, Flaherty J, Osinusi A, Liu Y, Merle U, Schulze Zur Wiesch J, Zeuzem S, Ciesek S, Cornberg M, Lampertico P; MYR 301 Study Group. A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D. N Engl J Med. 2023 Jul 6;389(1):22-32. doi: 10.1056/NEJMoa2213429. Epub 2023 Jun 22.

  PMID: 37345876 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples for HDV RNA measurement

MeSH Terms

Conditions

Hepatitis D

Interventions

bulevirtide; entecavir; Tenofovir; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

George Papatheodoridis, MD

CONTACT

+306946330639; gepapath@med.uoa.gr

Spyridoula Kardara

CONTACT

00302107231332; info@eligast.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Georgios Papatheodoridis

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 3, 2023
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

GR (1)