|Age:||18 years or older|
|Keywords:||hepatitis, hepatitis delta virus, hepatitis d, chronic Hepatitis Delta Virus, chronic hepatitis d|
|Type:||Drug study, Phase 3|
The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.
General Exclusions 1. Previous use of LNF within 12 months. 2. Current or previous history of decompensated liver disease. 3. Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable HIV RNA and HCV RNA, respectively. 4. Evidence of significant portal hypertension. 5. Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy. 6. History of hepatocellular carcinoma. 7. Patients with any of the following: - Current eating disorder - Evidence of alcohol substance use disorder. - Drug abuse within the previous 6 months before screening. 8. Prior history or current evidence of any of the following: - Immunologically mediated disease, - Retinal disorder or clinically relevant ophthalmic disorder, - Any malignancy within 5 years before screening, - Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease, - Chronic pulmonary disease, - Pancreatitis or colitis, - Severe or uncontrolled psychiatric disorder. 9. Other significant medical condition that may require intervention during the study. 10. Any condition that may impact proper absorption. 11. Therapy with an immunomodulatory agent, IFN-α (eg, IFN alfa-2a or IFN-alfa-2b, or pegylated IFN-alfa-2a or alfa 2b), cytotoxic agent, or chronic systemic corticosteroids within 12 months of screening. 12. Use of heparin or warfarin. 13. Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV. 14. Receipt of systemic immunosuppressive therapy. 15. History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG IFN-alfa-2a, tenofovir or entecavir.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.