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NCT Number: NCT04166266

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw for the laboratory assessment

Other

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.

Primary outcomes

  1. To study the natural or treated history of patients infected with HDV according to different management modalities.

    Time frame: At the end of the follow-up, december 2027

    This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.

Secondary outcomes

  1. Number of patient's reported outcomes measured with specific questionnaire

    Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment

  2. Quality of observance measured with specific questionnaire

    Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment

  3. Alcohol consumption (AUDIT-c), tobacco and cannabis use

    Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment

  4. Socio-economic situation measured with specific questionnaire

    Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment

  5. Quality of life level measured with short-form 12 (SF12) questionnaire

    Time frame: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment

  6. Rate of patients achieving HBV DNA indetectability

    Time frame: 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)

  7. Rate of early discontinuation of treatment due to an adverse event

    Time frame: At weeks 12, 24, 48, end of treatment

  8. HDV RNA level

    Time frame: 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)

  9. HDV RNA variation rate

    Time frame: 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)

  10. Breakthrough rate

    Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)

  11. Rate of sustained virological response

    Time frame: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)

    HDV RNA undetectability

  12. Rate of partial virological response

    Time frame: At weeks 4, 8, 12 and through the end of treatment (average 3 years)

    reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability

  13. Rate of patients achieving HBs seroconversion

    Time frame: 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)

  14. Virological response delay

    Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)

  15. Number of different HDV resistance variants

    Time frame: Through treatment period, average 3 years

  16. Number of patients with at least one resistance variant

    Time frame: Through treatment period, average 3 years

  17. Fibrosis level

    Time frame: 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)

  18. Rate of adverse event

    Time frame: 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)

  19. Death rate

    Time frame: 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)

  20. Liver transplantation rate

    Time frame: 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)

  21. Number and characterization of associated treatment with analogs and/or interferon

    Time frame: At weeks 4, 8, 12 and through the end of treatment (average 3 years

  22. Rate of patients presenting an evolution towards hepatocellular carcinoma

    Time frame: 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)

  23. Rate of patients presenting an evolution towards cirrhosis

    Time frame: 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)

    in non-cirrhotic patients

  24. Rate of patients presenting a decompensated cirrhosis

    Time frame: 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)

    in non-cirrhotic patients

  25. Change in HBs Ag from baseline

    Time frame: 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)

  26. Rate of biochemical response

    Time frame: 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)

    Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization

  27. Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive

    Time frame: 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)

  28. Rate of patients with appearance of anti-HBe Ab

    Time frame: 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)

  29. Rate of patients achieving HBe seroconversion

    Time frame: 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)

  30. Rate of spontaneous virological recovery

    Time frame: 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)

    Prolonged HDV RNA undetectability

  31. Rate of patients achieving HBs Ag negativation

    Time frame: 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)

  32. Rate of patients with appearance of anti-HBs Ab

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

COULIBALY Fatoumata

CONTACT

[email protected]

0144236110 ext. +33

Claire FOUGEROU-LEURENT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Acronym: HEPDELTA

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2019
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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