National Clinical Trial Number:NCT03719313
Clinical Trial Protocol Description:
: A phase 3, matrix design, partially double-blind, randomized study of the efficacy and safety of 50 mg lonafarnib/100 mg ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 weeks compared with PEG IFN-alfa-2a monotherapy and placebo treatment in patients chronically infected with hepatitis delta virus being maintained on anti-HBV nucleos(t)ide therapy (D-LIVR) protocol
The purpose of this study is to test an experimental study drug called LONAFARNIB either in combination with the FDA approved drugs ritonavir and pegylated interferon alpha or just in combination with ritonavir compared to placebo (a “sugar pill”, an inactive substance that contains no medicine but looks exactly the same).
This study is being done to assess whether Lonafarnib in combination with these drugs results in a decrease in the Hepatitis D viral load along with a normalization of specific liver enzymes. Study participants and the study staff will not know whether they are receiving study drug or placebo.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have documented chronic HDV infection for at least 6 months (RNA > 500).
- Have suppression of HBV; on therapy at least 12 weeks (entecavir or tenofovir).
- Have an ALT > 1.0 ULN.
You will be excluded from the study if any of the following criteria apply to you:
- Have decompensated liver disease or liver disease caused by other conditions.
- Are co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
- Have any malignancy within 5 years before screening.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.