HBeAg negative patients with chronic HBV infection will be allocated into two different cohorts, cohort A and cohort B. MedDRA version: 21.0 Level: PT Classification code 10052297 Term: Hepatitis B e antigen negative System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Hepatect CP
Pharmaceutical Form: Infusion
INN or Proposed INN: not applicable
Other descriptive name: HUMAN HEPATITIS B IMMUNOGLOBULIN
Concentration unit: IU/ml international unit(s)/milli
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 =65 years) no F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Clinically significant illness (other than hepatitis B) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol. Subjects currently under evaluation for a potentially clinically significant illness (other than hepatitis B) are also excluded. 2. Co-infection with hepatitis C virus (defined as HCV RNA positive. HCV RNA negative/anti-HCV-positive patients can be included) or co-infection with HIV. 3. Clinical hepatic decompensation (i.e. clinical ascites, encephalopathy or variceal hemorrhage). 4. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included. 5. Significant drug allergy (such as anaphylaxis or hepatotoxicity). 6. Pregnant or nursing female or male with pregnant female partner 7. Clinically relevant drug or alcohol abuse within 12 months of screening including any uncontrolled drug use within 6 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication. The investigator must approve medication, the diagnosis and prescription. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study. 8. live-attenuated virus vaccinations such as: measles, mumps, rubella and varicella 4 weeks before and up to three months after administration of hepatitis B immunoglobulins. If not required by an emergency situation, passive or active immunizations or administration of plasma preparations or of other immunoglobulins is not allowed during the study. 9. A recent SARS-COV2 infection in the last 4 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is as follows: - 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 ;Secondary Objective: The secondary objectives of this study are as follows: - To analyze the decline of HBsAg during treatment - To evaluate the post-treatment HBsAg kinetics/response - To determine HBV-DNA levels during and after treatment with hepatitis B immunoglobulins - To evaluate the biochemical disease activity (normalization of serum ALT levels) - To determine the quality of life (SF-36) Assessment of safety: Adverse events (AEs) will be collected throughout the study (upon first administration of the IMPs up to 24 weeks after discontinuation of therapy, FU24). ;Primary end point(s): Primary efficacy endpoint: - HBsAg negativity at week 12 of antiviral therapy;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint(s): 1) HBsAg decline at weeks 1, 2, 4, 8 and 12 of treatment 2) post-treatment HBsAg negativity up to FU week 24 3)HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort 4) biochemical response (proportion of subjects who reached ALT normalization (ALT = ULN) at week 12 of treatment) 5) quality of life during treatment and follow-up (SF-36) 6)Assessment of safety: 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. ;Timepoint(s) of evaluation of this end point: 1) weeks 1, 2, 4, 8 and 12 of treatment 2) up to FU week 24 3)during and after hepatitis B immunoglobulin treatment 4) week 12 5)during treatment and follow-up 6)upon first administration of the IMPs up to 24 weeks after discontinuation of therapy, FU24 | — |
Countries
Germany
Contacts
Public ContactDepartment of Gastroenterology
Medical School Hannover
Outcome results
None listed