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

NCT03600714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-12-14

Study results available
· View outcomes & findings →

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

Conditions

Interventions

DRUG

Peg-interferon lambda

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

DRUG

Lonafarnib

Oral prenylation inhibitor

DRUG

Ritonavir

Booster of lonafarnib action

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Christopher Koh, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-02-05
Completion
2020-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600714 on ClinicalTrials.gov