Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis… (NCT05229991) | Clinical Trial Compass
CompletedPhase 3
Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection
Israel, New Zealand, Turkey (Türkiye)10 participantsStarted 2021-05-15
Plain-language summary
Open label, single arm, multi-center clinical trial of lonafarnib 50 mg QD plus ritonavir 200 mg QD, administered orally, over a 48-week treatment period, with a 24-week post-treatment follow-up period, in patients with chronic Hepatitis D Virusinfection.
Objectives: To evaluate the safety and tolerability of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period.
To evaluate the effect of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period with a 24-week post-treatment follow-up on HDV viral levels.
Trial population: Up to 30 patients with chronic HDV infection with detectable HDV RNA and compensated liver disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Chronic HDV infection, with compensated liver disease, documented by a positive HDV antibody (Ab) test and HDV RNA by quantitative polymerase chain reaction (qPCR) assay, prior to initiation of trial treatment.
. Demonstrable suppression of HBV DNA (\< 100 IU/mL) following anti-HBV nucleos(t)ide treatment prior to initiating trial therapy.
. Willing and able to comply with trial procedures and provide written informed consent.
. ALT \> ULN documented on at least one occasion during the 12 months preceding enrollment to the trial.
. Male and female participants who are 18 years of age or above.
. ECGs demonstrating no acute ischemia or clinically significant (CS) abnormality and a corrected QT interval by Fridericia correction formula (QTcF) \< 450 ms in males and \<470 ms in females.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Sexually active female patients of childbearing potential and sexually active male patients with partners of childbearing potential must agree to use adequate methods of contraception during the trial. Females of childbearing potential are all those except women who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
Exclusion criteria
. Participation in a clinical trial with, or use of, any investigational agent within 30 days or 5 half-lives, whichever is longer, before starting LNF treatment.
. Female patients who are pregnant or breastfeeding. Female patients must have a negative serum test at screening and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[hCG\] at baseline, within 24 hours prior to the start of any investigational agent). Male patients with female sexual partners who are pregnant.
. Current or previous history of decompensated liver disease (e.g. variceal bleeding, ascites, hepatic encephalopathy, hepatorenal syndrome).
. Creatinine clearance (\< 30 mL/min by Cockroft-Gault).
. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV). Patients with a positive HCV Ab at baseline are allowed if they have completed a curative antiviral regimen and have documented undetectable HCV RNA 12 weeks or more following last dose of anti-HCV medications.
. Abnormal thyroid-stimulating hormone (TSH) or free thyroxine (fT4) levels. Patients with well-controlled thyroid function or TFTs that are not clinically significant may be enrolled.
. Evidence of another form of viral hepatitis or another form of liver disease (eg, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, alcoholic liver disease, nonalcoholic steatohepatitis, hemochromatosis, alpha 1 anti-trypsin deficiency).