National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses (HEPDELTA)

This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis D, Chronic; Hepatitis B, Chronic
• Intervention / Treatment: Other: Blood draw for the laboratory assessment

Detailed Description

This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:

• Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
• Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.

Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:

• Samples for the biobank,
• Self-administered questionnaires.

In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Claire FOUGEROU-LEURENT; Email: claire.fougerou@chu-rennes.fr
• Study Contact Backup: Name: COULIBALY Fatoumata; Phone Number: +33 0144236110; Email: fatoumata.coulibaly@anrs.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU of Angers
    • Contact: Isabelle FOUCHARD
  • Annecy, France
    • Not yet recruiting
    • Centre Hospitalier de la région annécienne
    • Contact: Frederic HELUWAERT
  • Bobigny, France
    • Recruiting
    • Avicenne Hospital
    • Contact: Nathalie GANNE
  • Bobigny, France
    • Recruiting
    • Avicenne Hospital - Hepatology
    • Contact: Dominique ROULOT
  • Bordeaux, France
    • Recruiting
    • Haut Lévêque Hospital
    • Contact: Juliette FOUCHER
  • Clermont-Ferrand, France
    • Recruiting
    • Estaing Hospital
    • Contact: Armand ABERGEL
  • Clichy, France
    • Recruiting
    • Beaujon Hospital
    • Contact: Tarik ASSELAH
  • Créteil, France
    • Recruiting
    • Henri Mondor Hospital
    • Contact: Vincent LEROY
  • Créteil, France
    • Recruiting
    • Centre Hospitalier Intercommunal
    • Contact: Isabelle ROSA
  • Dijon, France
    • Recruiting
    • Bocage Hospital
    • Contact: Anne MINELLO
  • Grenoble, France
    • Recruiting
    • Michallon Hospital
    • Contact: Marie-Noëlle HILLERET
  • Lille, France
    • Recruiting
    • Claude Huriez hospital
    • Contact: Philippe Mathurin
  • Limoges, France
    • Recruiting
    • Dupuytren Hospital
    • Contact: Véronique LOUSTAUD-RATTI
  • Lyon, France
    • Recruiting
    • Hôpital de la Croix Rousse
    • Contact: Fabien ZOULIM
  • Lyon, France
    • Recruiting
    • Edouard Herriot Hospital
    • Contact: Jérôme DUMORTIER
  • Lyon, France
    • Recruiting
    • Croix Rousse Hospital
    • Contact: Dulce ALFAIATE
  • Marseille, France
    • Recruiting
    • Saint Joseph Hospital
    • Contact: Marc BOURLIERE
  • Montpellier, France
    • Recruiting
    • Saint Eloi Hospital
    • Contact: Magdalena MESZAROS
  • Nantes, France
    • Recruiting
    • Hotel-Dieu Hospital
    • Contact: François RAFFI
  • Nantes, France
    • Recruiting
    • Hotel Dieu Hospital
    • Contact: Jérôme GOURNAY
  • Nice, France
    • Recruiting
    • l'Archet 2 Hospital
    • Contact: Albert TRAN
  • Orléans, France
    • Recruiting
    • La Source Hospital
    • Contact: Xavier CAUSSE
  • Paris, France
    • Recruiting
    • Cochin Hospital
    • Contact: Stanislas POL
  • Paris, France
    • Recruiting
    • Hopital Tenon
    • Contact: Julie CHAS
  • Paris, France
    • Recruiting
    • La Pitié Salpêtrière Hospital
    • Contact: Vlad Ratziu
  • Paris, France
    • Not yet recruiting
    • Lariboisiere Hospital
    • Contact: Myriam DIEMER
  • Paris, France
    • Recruiting
    • Pitié-Salpêtrière Hospital
    • Contact: Marc-Antoine VALANTIN
  • Paris, France
    • Recruiting
    • Bichat-Claude Bernard Hospital
    • Contact: Anne GERVAIS
  • Paris, France
    • Recruiting
    • Saint Louis Hospital
    • Contact: Caroline LASCOUX-COMBE
  • Paris, France
    • Recruiting
    • Saint Antoine Hospital
    • Contact: Olivier CHAZOUILLERES
  • Paris, France
    • Recruiting
    • Saint-Antoine Hospital
    • Contact: Karine LACOMBE
  • Rennes, France
    • Recruiting
    • Pontchaillou Hospital
    • Contact: Caroline JEZEQUEL
  • Rouen, France
    • Recruiting
    • Charles Nicolle Hospital
    • Contact: Ghassan RIACHI
  • Strasbourg, France
    • Recruiting
    • Nouvel Hôpital Civil
    • Contact: Simona TRIPON
  • Toulouse, France
    • Recruiting
    • Hôpital Rangueil
    • Contact: Laurent ALRIC
  • Toulouse, France
    • Recruiting
    • Rangueil Hospital
    • Contact: Sophie METIVIER
  • Tours, France
    • Recruiting
    • Trousseau Hospital
    • Contact: Louis d'ALTEROCHE
  • Villejuif, France
    • Recruiting
    • PAUL BROUSSE HOSPITAL
    • Contact: Bruno ROCHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included.

Patients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.

Description

Inclusion Criteria:

• Age > 18 years,
• Presenting a chronic HDV infection (positive serology),
• Who gave his written informed consent before any intervention and the day of inclusion at the latest,
• Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).

Exclusion Criteria:

• Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
• Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
• Patients with predictable difficulties of follow-up according to the investigator.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with co-infection with hepatitis B and Delta viruses,; Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.	Other: Blood draw for the laboratory assessment; Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the natural or treated history of patients infected with HDV according to different management modalities.	This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.	At the end of the follow-up, december 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient's reported outcomes measured with specific questionnaire		weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of observance measured with specific questionnaire		weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Alcohol consumption (AUDIT-c), tobacco and cannabis use		weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Socio-economic situation measured with specific questionnaire		weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of life level measured with short-form 12 (SF12) questionnaire		At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Rate of patients achieving HBV DNA indetectability		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of early discontinuation of treatment due to an adverse event		At weeks 12, 24, 48, end of treatment
HDV RNA level		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
HDV RNA variation rate		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Breakthrough rate		At weeks 8, 12 and through the end of treatment (average 3 years)
Rate of sustained virological response	HDV RNA undetectability	At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)
Rate of partial virological response	reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability	At weeks 4, 8, 12 and through the end of treatment (average 3 years)
Rate of patients achieving HBs seroconversion		At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Virological response delay		At weeks 8, 12 and through the end of treatment (average 3 years)
Number of different HDV resistance variants		Through treatment period, average 3 years
Number of patients with at least one resistance variant		Through treatment period, average 3 years
Fibrosis level		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of adverse event		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Death rate		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Liver transplantation rate		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Number and characterization of associated treatment with analogs and/or interferon		At weeks 4, 8, 12 and through the end of treatment (average 3 years
Rate of patients presenting an evolution towards hepatocellular carcinoma		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting an evolution towards cirrhosis	in non-cirrhotic patients	At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting a decompensated cirrhosis	in non-cirrhotic patients	At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Change in HBs Ag from baseline		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of biochemical response	Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization	At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBe Ab		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBe seroconversion		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of spontaneous virological recovery	Prolonged HDV RNA undetectability	At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBs Ag negativation		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBs Ab		At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Study Director: Fabien ZOULIM, Hôpital de la Croix-Rousse

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: treatment; safety; efficacy; evolution
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Hepatitis D; Hepatitis D, Chronic
• Other Study ID Numbers: ANRS HD EP01-HEPDELTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No