B18.0
Conditions
Interventions
Group 1: Out of the retrospective cohort it is planned to recruit 50 patients with replicating chronic hepatitis D in proven HBV/HDV coinfection and monitor those prospectively to baseline and after o
Sponsors
ZIM1 of the University Hospital of the J.W. Goethe-University (Direktor: Prof. Dr. S. Zeuzem) Universitätsklinikum Frankfurt a.M.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Retrospective cohort: All anti-HDV antibody and/or HDV-RNA positive patients seen at the participating sites between the 01st of January 2016 and the 31st of December 2021 are eligible for the retrospective cohort. Prospective cohort: Patients eligible to participate in the prospective study need to fullfill the following inclusion criteria: • Patient is able and willing to give written informed consent for participation after appropriate information about the study participation plus • Patient has attended study site for a minimum of two visits before inclusion in the study plus • anti-HDV antibody positive patient with detectable HBs antigen and detectable HDV RNA at baseline or • anti-HDV antibody positive patients receiving or having received interferonalpha and/or bulevirtide with detectable HBs antigen at baseline and detectable HDV RNA in the past.
Exclusion criteria
Exclusion criteria: retrospective cohort: none prospective cohort: • Patient unable or unwilling to give informed consent; • patient with HIV coinfection and/or active HCV coinfection; • patient with relevant comorbidity (e.g. malignancy other than HCC, decompensated cardiac or pulmonary disease) disabling comparison with the rest of the cohort to the opionion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with (1) replicating CHD (as defined by (1) positive serum HDV-RNA) / / (2) active CHD (defined by positive serum HDV-RNA AND elevated alaninaminotransferase (ALT)), among patients with detectable anti-HDV antibodies when testing was done in a participating hepatology out patient clinic | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the secondary outcome is planned for the prospective subgroup: -Rate of medical care uptake among CHD patients with indication for surveillance. (Medical care uptake is defined by the number of clinical follow up visits at the study sites during the clinical follow up period. The clinical follow up period starts at the date of the patients first attendance and ends with the date of the study assessment. -Maximum clinical assessment intervals (delta cTmax) are chosen with the double time period of the recommended assessment intervals from the national HBV S3-guideline to allow a tolerance in visit intervals and thereby reduce loss of follow up: * Clinical attendance once yearly for HDV coinfected patients without active HDV or HBV infection. * Clinical attendance every 6 months for HDV coinfected patients with evidence of active HDV or HBV infection. *Clinical attendance every 6 months for HDV coinfected patients with evidence for liver cirrhosis. *Clinical attendance every 6 months for HDV coinfected patients receiving antiviral therapy for either HBV and/or HDV. The number of clinical follow up visits is standardized by the follow up interval (delta Tfu) and the maximum minimum required clinical assessment intervals (delta cTmax). CA(%)= n(CA) x (delta cTmax /delta Tfu) x100 -Maximum sonographic assessment intervals (detla sTmax) are choosen in accordance with recent national guidelines for chronic HBV infection due to the indicated tumor surveillance with abdominal ultrasound scan: * Sonographic screening once yearly for HDV infected patients without active HDV infection (normal ALT, no HDV replication, HBs Ag positive) * Sonographic screening once yearly for patients with evidence for active HDV infection (HDV RNA positive and ALT > ULN) *Sonographic screening every 6 months for HDV infected patients with evidence for liver cirrhosis. The number of sonographic assessments is standardized by the follow up interval (delta sTfu) and the m | — |
Countries
Germany
Contacts
Public ContactKathrin Sprinzl
ZIM1 of the University Hospital of the J.W. Goethe-University (Direktor: Prof. Dr. S. Zeuzem) Universitätsklinikum Frankfurt a.M.
Outcome results
None listed