CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Peg-interferon lambda +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03600714
NCT03600714Phase 2Completed

Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 26, 2018·Updated Dec 14, 2021

In Brief

A Phase 2 clinical trial evaluating Peg-interferon lambda, Lonafarnib, and 1 other intervention for Liver Disease and Hepatitis D. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver. Objectives: To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection. Eligibility: Adults at least 18 years old with chronic hepatitis D infection Design: Participants will be screened with a physical exam, medical history, and blood and urine tests. Throughout the study, all participants will: * Follow rules for medicine, food, and contraception * Take hepatitis B medicine * Have weight checked * Have routine blood and urine tests * Give stool samples * Female participants will have pregnancy tests. Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan. Participants will have a 5-day inpatient stay. They will: * Baseline blood and urine tests * Have eye tests * Answer health questions * Have a liver sample taken and liver blood pressure measured. Participants will be sedated. * Have reproductive tests * Start the study drugs and have blood draws Over 24 weeks of treatment, participants will: -Take 2 study drugs by mouth every day and 1 as a weekly injection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 26, 2018
Enrollment StartAug 1, 2018
Primary CompletionFeb 5, 2020
Study CompletionAug 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.9 years ago

Interventions

Peg-interferon lambdadrug

Peg-interferon Lambda is a covalent conjugate of human recombinant non- pegylated interferon (IFN) lambda and a 20-kDa linear pegylated (PEG) chain.

Lonafarnibdrug

Oral prenylation inhibitor

Ritonavirdrug

Booster of lonafarnib action