A Non-interventional Registry for Patients with Hepatitis B Virus Infection

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Hepatitis B Virus Infection

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05051098

848223 (Other Grant/Funding Number)

3374-2016

05.220 (Other Grant/Funding Number)

Details and patient eligibility

About

In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.

Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.

Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hepatitis B Virus Infection

TherVacB sub-cohort:

• confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
• HBeAg status documented for at least 6 months

Exclusion criteria

TherVacB sub-cohort:

• age >70 years
• co-infection with HIV, HCV (RNA positive),
• clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
• significant comorbidities (e.g. malignancies)
• immunosuppressive treatment (> 40 mg Cortisol- equivalent)
• liver cirrhosis (judged clinically or based on ultrasound/transient elastography)
• History of hepatocellular carcinoma

Trial design

3,000 participants in 1 patient group

TherVacB Subgroup

Description:

No interventions. The participating study centers of the EU funded project "TherVacB" recruit patients with stricter inclusion- and exclusion criteria, hence forming a sub-cohort.

Treatment:

Other: No intervention