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Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

NCT05345990 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-04

No results posted yet for this study

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®.

Conditions

Interventions

DRUG

Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)

Hepatect® is a solution to be administered Intravenously. Zutectra® is a solution to be administered subcutaneously. Treatment for 12 weeks with hepatitis B immunoglobulins with following administration scheme: D0: 10.000 IU Hepatect® i.v. D1-6: 500 IU Zutectra® s.c. D7: 10.000 IU Hepatect® i.v. D9- D84: 500 IU Zutectra® s.c. every 2nd day

Sponsors & Collaborators

  • Biotest

    collaborator INDUSTRY

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Heiner Wedemeyer, Prof. · Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345990 on ClinicalTrials.gov