Chronic Hepatitis B
Conditions
Keywords
Human hepatitis B Immunoglobulin
Brief 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®.
Interventions
DRUGHuman 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
Biotest
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients treated in two cohorts for 12 weeks with hepatitis B immunoglobulins
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Willing and able to provide written informed consent 2. Male or female, age ≥ 18 years 3. Confirmation of chronic HBV infection documented by: positive HBsAg at least 12 months before screening 4. Cohort A: NA treatment for at least 12 months before screening. HBV-DNA should be below the lower limit of detection at screening. HBsAg positive and \<100 IU/ml. HBeAg negative. 5. Cohort B: Untreated with NAs for at least 12 months before screening. HBV-DNA \< 2000 IU/ml. HBsAg positive and \< 100 IU/ml. HBeAg-negative. 6. Subject has not been treated with any investigational drug or device within 42 days before the screening visit or within 5 half-lives for investigational drugs, whichever is longer. 7. Transient Elastography (FibroScan) \< 7.5 kPa at screening. 8. ALT levels \< 1.5 times of upper the limit of normal at screening for both cohorts 9. Body mass idex (BMI) \> 18kg/m² 10. A negative serum pregnancy test is required for female subjects (unless surgically sterile or women \> 54 years of age with cessation for \> 24 months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) is not permitted. Or Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of FU: * intrauterine device (IUD) with a failure rate of \< 1% per year * bilateral tubal sterilization * vasectomy in male partner * hormone-containing contraceptive: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable 11. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of 12-weeks treatment with hepatitis B immunoglobulins in two different cohorts of patients with chronic hepatitis B defined by the proportion of subjects being HBsAg negative at treatment week 12 | week 12 of antiviral therapy | Primary efficiency endpoint: HBsAg negativity at week 12 of antiviral therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the post-treatment HBsAg kinetics/response | Follow-up (FU) week 2, FU week 4, FU week 12 and FU week 24 | Secondary endpoint: Post-treatment HBsAg negativity up to FU week 24 |
| To determine HBV-DNA levels during and after treatment with hepatitis B immunoglobulins | screening, day 0, day 1, day 3, day 7, day 28, day 42, day 84, FU week 12 and FU week 24 | Secondary endpoint: HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort. |
| To analyze the change/decline of HBsAg during treatment | week 1, 2, 4, 8 and 12 of treatment | Secondary endpoint: HBsAg change/decline at weeks 1, 2, 4, 8 and 12 of treatment |
| To determine the quality of life by SF-36 questionnaire | day 0, day 84, FU week 12, FU week 24 | Secondary endpoint: quality of life during treatment and follow-up (SF-36) |
| Assessment of safety by collection of adverse events (AEs) as frequencies (absolute/relative). | day 0, day 1, day 3, day 7, day 14, day 21, day 28, day 42, day 56, day 84, FU week 2, FU week 4, FU week 12, FU week 24 | Adverse events (AEs) will be collected throughout the study (upon first administration of the IMPs up to 24 weeks after discontinuation of therapy, FU24) and will be reported with absolute and relative frequencies along with the corresponding 95% confidence intervals |
| To evaluate the biochemical disease activity (normalization of serum ALT levels) | week 12 of treatment | Secondary endpoint: biochemical response (proportion of subjects who reached ALT normalization (ALT ≤ ULN) at week 12 of treatment) |
Countries
Germany
Outcome results
None listed