Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
HepB mAb19
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 to ≤ 70;
HBV infection confirmed by positive HBsAg for ≥6 months;
On HBV-active nucleos(t)ide therapy for ≥6 months without change in NRTI in theprevious 3 months;
The following laboratory values 49 days prior to study entry (day 0):
HBV DNA below lower limit of quantification;
HBs antibody negative;
HBeAg negative;
Ability and willingness to provide informed consent.
For participants who can become pregnant (i.e., participants who have not beenpost-menopausal for at least 24 consecutive months, who have had menses within thepreceding 24 months, or who have not undergone surgical sterilization, specificallyhysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negativeserum or urine pregnancy test at screening and on day 0 (study entry).
Participants who can become pregnant must agree to use two methods of contraception,one of which must be from the highly effective methods for contraception listedbelow. Barrier methods of contraception are permitted for the second method ofcontraception. Contraception must be used from 10 days prior to study entry andduring study follow up. Acceptable methods of contraception include:
Contraceptive subdermal implant;
Intrauterine device or intrauterine system;
Combined estrogen and progestogen oral contraceptive;
Injectable progestogen;
Contraceptive vaginal ring;
Percutaneous contraceptive patches;
Partner sterilization with documentation of azoospermia prior to theparticipant's entry into the study, and this partner is the sole partner forthat participant. The documentation of partner sterility can come from the sitepersonnel's review of medical records or medical history interview provided bythe participant or the partner. Self-reported documentation of reproductivepotential should be entered in the source documents.
Participants who can impregnate a partner and who are engaging in sexual activitythat could lead to pregnancy must agree to use condoms from 10 days prior to studyentry and during study follow up to avoid impregnating a partner who can getpregnant.
Exclusion
Exclusion Criteria:
Clinical symptoms, imaging studies or liver histology suggestive of advancedfibrosis (exclude fibrosis grade 3 and 4 by FibroScan) (Fibroscan®< 9 kpa) 12months prior to entry or done at the pre-infusion visit. Note: If FibroScan resultsare not available, imaging will be performed at the preinfusion visit.
Presence of a LI-RADS4 or 5 liver lesion on imaging 12 months prior to entry or doneat pre-infusion visit, if prior results not available.
Alpha fetoprotein >20 ng/ml. Note: Alpha-fetoprotein (AFP) above normal but < 20 is acceptable for entry if earlier AFP levels (older than 6 months) are withinnormal range and imaging is negative in last 3 months).
HIV-1, HCV or hepatitis delta virus infection 12 months prior to entry or done atscreen, if prior results not available;
History of hematopoietic stem cell transplant or solid organ transplant;
Any confirmed significant allergic reactions (urticaria or anaphylaxis) against anydrug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hayfever is acceptable);
History of cardiovascular disease (e.g., cardiac insufficiency, coronary arterydisease, cardiomyopathy, congestive heart failure, family history of congenital longQT syndrome, family history of sudden death);
History or presence of clinically significant Electrocardiogram (ECG) abnormalitiesbased on the average of the triplicate ECG recordings (e.g., PR interval >210 ms,QT corrected for heart rate using the Fridericia's correction factor [QTcF] > 450ms for males and QTcF >470 ms for females);
History of systemic corticosteroids, immunosuppressive anti-cancer, systemicinterferons or interleukins 6 months prior to entry;
History of chronic liver disease from another cause, ICD, or autoimmune diseasesthat in the opinion of the investigator would preclude participation;
Any significant acute infection (e.g. influenza, COVID-19) or any other clinicallysignificant illness 2 weeks prior to entry.
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count <1,000 /mm3
Hemoglobin <10 gm/dL (6.21 mmol/L)
Platelet count <150,000 /mm3
ALT >2.0 x Upper normal limit (ULN)
AST >2.0 x ULN
Total bilirubin >1.5 ULN (except individuals with known Gilbert's)
Albumin <3.5 gm/dL
Estimated glomerular filtration rate (eGFR) <70 mL/min
INR ≥1.2
Pregnancy or lactation;
Any vaccination 2 weeks prior to entry;
Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);
Participation in another clinical study of an investigational product currently or 12 weeks prior to, or expected participation during this study
Study Design
Study Description
Connect with a study center
Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, 8200
DenmarkActive - Recruiting
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