The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. The main questions it aims to answer are: Does drug RBD106 reduce the HDV RNA levels? What medical problems may participants experience when taking drug RBD1016? Researchers will compare drug RBD1016 to a placebo to see if drug RBD1016 works to treat chronic hepatitis D. Participants will: Receive drug RBD1016 or a placebo several times throughout the trial. Visit the clinic once every 4-6 weeks for checkups and tests.
This is a multicentre, randomised, partly blinded, placebo-controlled clinical trial to evaluate the efficacy, safety and pharmacokinetics (PK) of RBD1016 subcutaneous injections in participants with chronic HDV infection. First part of the trial: There will be 2 treatment groups - an active group (n=10) and a deferred active group (n=5), with participants allocated randomly. In the active group, participants will receive RBD1016. In the deferred active group, participants will receive 4 doses of placebo followed by deferred treatment with doses of RBD1016. Both groups will be on a stable nucleoside analogue (NA) treatment course during the trial . All participants will be blinded to the trial treatment for the 16 weeks after the first dose. Then, investigators and other clinic staff will be unblinded, i.e., they will know which treatment the participants receive at all times. Open-label extension part (site 01 only): continued IMP-treatment with additionally 3 doses of IMP administered 12 weeks apart. This part of the trial is conducted to collect long-term safety data and further exploratory efficacy measures. Only participants who may benefit from continued treatment in the ,trial, according to the judgement of the investigator, will be eligible for the open-label extension part of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Medicinsk enhet för Infektionssjukdomar, Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Infektionskliniken, Danderyds sjukhus
Stockholm, Sweden
Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).
Time frame: 60 weeks
Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.
Number and percentage of participants with AEs, SAEs and AEs of interest. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).
Time frame: 60 weeks
Mean change (log10 value) in HBsAg levels vs. baseline, at end of trial (Week 60).
Time frame: 60 weeks
Proportion of participants with positive immunogenicity, measured as plasma concentrations of anti-drug antibodies (ADAs), at each evaluation time point up to end of the study at week 60.
Time frame: 60 weeks
Mean maximum change (log10 value) in HDV RNA levels in plasma vs. baseline, at any timepoint during the study, and up to the end of study at Week 60.
Mean maximum change refers to the average of the largest changes in HDV RNA levels.
Time frame: Up to 60 weeks
Mean maximum change (log10 value) in HBsAg levels vs. baseline, at any timepoint during the study, and up to end of study at Week 60.
Mean maximum change refers to the average of the largest changes in HBsAg levels.
Time frame: Up to 60 weeks
For participants with HBsAg levels more than100 IU/mL at baseline: Proportion of participants with HBsAg levels ≤ 10 IU/mL at end of trial (Week 60).
Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.
Time frame: 60 weeks
Proportion of participants with undetectable HDV RNA (i.e., less than the limit of detection), or ≥ 2 log10 decrease in HDV RNA and alanine transaminase (ALT) normalisation, at end of trial (Week 60).
Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.
Time frame: 60 weeks
Proportion of participants with undetectable HDV RNA (i.e., less than the limit of detection) or ≥ 2 log10 decrease in HDV RNA at end of trial (Week 60).
Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.
Time frame: 60 weeks
Plasma concentrations of RBD1016.
Time frame: 60 weeks
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