Clinical Trial: Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With Chronic Hepatitis Delta

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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

Detailed Summary:

The study is designed to evaluate safety and efficacy of MXB in a subset of HBV infected patients who are co-infected with hepatitis delta virus (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 pegylated interferon-alpha-2a (further PEG-INF-a) treatment versus a combination of both drugs versus pegylated interferon-alpha-2a.

Prolonged blockade of HBV entry into hepatocytes should also block infection with HDV particles (which uses 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, HDV RNA, HBV DNA), as well as safety and tolerability and drug immunogenicity.

Sponsor: Hepatera Ltd.

Current Primary Outcome: Improvement in quantitative serum HBsAg levels after 12 weeks of therapy [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hepatera Ltd.

Dates:
Date Received: December 17, 2015
Date Started: March 2014
Date Completion: February 2016
Last Updated: December 20, 2015
Last Verified: December 2015