drugset
drugset / Trial / NCT05345990

Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

NCT05345990 ↗

Phase 2 Terminated 13 enrolled Hannover Medical School Biotest · collab
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single arm (two cohorts), single-center, phase II pilot-study to provide preliminary evidence whether hepatitis B immunoglobulins (HBIG) are efficacious and can be safely used in patients with chronic Hepatitis B Virus (HBV) infection. A total of 20 patients (male or female adults aged ≥ 18 years) will be enrolled in the study and receive hepatitis B immunoglobulins Hepatect®CP and Zutectra®.

Timeline

Start
2022-08-15
Primary completion
2025-07-31
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject hepatitis B immune globulin Protein / enzyme biologic 500 iu Intravenous
Subject hepatitis B immune globulin Protein / enzyme biologic 10000 iu Intravenous

Indications

chronic hepatitis B virus infection