Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus (HBV) co-infected with hepatitis delta virus (HDV).
The study is designed to evaluate safety and efficacy of MXB in a subset of HBV infected patients who are co-infected with HDV. Hepatitis delta represents the most severe form of chronic viral hepatitis and there is no approved treatment option available for patients infected with both HBV and HDV. 24 patients will be randomised into 3 arms: pre-treatment with MXB followed by PEG-INF-a treatment versus a combination of both drugs versus PEG-INF-a. Prolonged blockade of HBV entry into hepatocytes should also block infection with HDV particles (which uses hepatitis B surface antigen (HBsAg) as its envelope) and thus provide a therapeutic option for this otherwise hardly treatable disease. PEG-INF-a is used for the treatment of chronic hepatitis delta. The study endpoints are virological response (HBsAg, hepatitis delta virus ribonucleic acid (HDV RNA), hepatitis B virus deoxyribonucleic acid (HBV DNA)), as well as safety and tolerability and drug immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy
HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 12 compared to baseline (including the patient with negative baseline level)
Time frame: Baseline and 12 weeks
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy
HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 24 compared to baseline (including the patient with negative baseline level)
Time frame: Baseline and 24 weeks
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy
HBV DNA response was defined as persistent reduction of HBV DNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level)
Time frame: Baseline and 24 weeks
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy
HBV DNA response was defined as persistent reduction of HBV DNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level)
Time frame: Baseline and 12 weeks
Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy
HDV RNA response was defined as persistent reduction of HDV RNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level)
Time frame: Baseline and 12 weeks
Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HDV RNA response was defined as persistent reduction of HDV RNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level)
Time frame: Baseline and 24 weeks
Number of Participants With Biochemical Response at Week 12 of Therapy
Biochemical response was defined as normalization of ALT level as compared to baseline.
Time frame: Baseline and 12 weeks
Number of Participants With Biochemical Response at Week 24 of Therapy
Biochemical response was defined as normalization of ALT level as compared to baseline.
Time frame: Baseline and 24 weeks
Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy
Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up.
Time frame: Baseline and 72 weeks for arm A and 48 weeks for arms B and C