Chronic Hepatitis D Infection Clinical Trial
Official title:
Randomized Open-label Substudy of Daily Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative Chronic Hepatitis B Co-infected With Hepatitis Delta
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.
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