A Study of the Safety and Effectiveness of Experimental Lonafarnib / Ritonavir for Chronic Hepatitis D Virus Infection

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: hepatitis, hepatitis delta virus, hepatitis d, chronic Hepatitis Delta Virus, chronic hepatitis d
Type: Drug study, Phase 3
Target:
2 Participants
Investigator:
Description
This study is for patients with chronic (long-lasting) hepatitis D virus (HDV) infection. Potential participants must be taking or be willing to begin taking nucleotide/nucleoside inhibitors (entecavir or tenofovir). These nucleotide/nucleoside inhibitors must be taken for at least 12 weeks to 6 months before beginning the study treatment.

The purpose of this study is to determine whether the study drugs will reduce the amount of HDV in your blood.

Other purposes of this study are:
- to determine the effects of the study drugs on your liver
- to determine if taking the study drugs makes your quality of life better
- to evaluate the safety of the study drugs

The Sponsor is conducting this study to find new treatments for HDV. This research study is designed to learn more about an investigational drug called lonafarnib. It is being developed to treat chronic HDV infection as well as other conditions. "Investigational" means lonafarnib is not yet approved by the FDA for prescription or over the-counter (OTC) use.

Lonafarnib will be taken in combination with an approved drug called ritonavir. Ritonavir is commonly used in the treatment of hepatitis C at comparable dosing to what will be used in this study. In this study, ritonavir is used as a “booster” to increase the amount of lonafarnib in your body. A “booster” is a drug that prevents your body from breaking down lonafarnib, so it can work longer.

Some patients in this study will take an interferon medicine approved for treating HBV and hepatitis C virus (HCV) infections. This medicine is called peginterferon-alfa-2a (abbreviated as PEG IFN-alfa-2a). PEG IFN-alfa-2a will be a potential added medicine in this study. We hope to determine if it improves the treatment outcome when taken with lonafarnib and ritonavir. Peginterferon-alfa-2a is a solution that is injected under the skin once per week.
This study requires

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.

Who can participate

Inclusion criteria:

  1. Chronic HDV infection for at least 6 months in duration, documented by a positive HDV antibody test and HDV RNA ≥ 500 IU/mL. Note: All genotypes of HDV permitted.
  2. Demonstrable suppression of HBV DNA following at least 12 weeks of anti-HBV nucleos(t)ide treatment with entecavir or tenofovir prior to initiating therapy.
  3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.
  4. Baseline liver biopsy demonstrating evidence of chronic hepatitis.
  5. ECGs demonstrating no acute ischemia or clinically significant abnormality.
  6. Normal dilated retinal examination.

Exclusion criteria:

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.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $60.00 per visit for your time and effort. You will also be compensated $25 for a meal. Subjects will receive their compensation quarterly in the form of a check by mail.
Resources
Schedule
Study duration and period
You may participate in this study for up to 2 years total.
Recruitment period
From July 8, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sophia Zaragoza
Research Topic
Conditions:
  • Hepatitis Delta Virus

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview