Blood draw for the laboratory assessment
OtherBlood 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.
NCT Number: NCT04166266
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU of Angers, Angers, France
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:
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Time frame: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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)
Time frame: At weeks 12, 24, 48, end of treatment
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)
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)
Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)
Time frame: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)
HDV RNA undetectability
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
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)
Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)
Time frame: Through treatment period, average 3 years
Time frame: Through treatment period, average 3 years
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)
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)
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)
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)
Time frame: At weeks 4, 8, 12 and through the end of treatment (average 3 years
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)
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
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
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)
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
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)
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)
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)
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
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)
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)
Contact information is provided by the study sponsor or research team.
ANRS, Emerging Infectious Diseases
Other Gov
Acronym: HEPDELTA
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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