CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Lonafarnib +1 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/NCT01495585
NCT01495585Phase 2Completed

Treatment of Chronic Delta Hepatitis With Lonafarnib

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Dec 20, 2011·Updated Aug 31, 2016

In Brief

A Phase 2 clinical trial evaluating Lonafarnib and Placebo for Hepatitis D. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Background: * Chronic hepatitis D is a severe disease of the liver caused by infection with the hepatitis D virus. The hepatitis D virus can only infect a person who also has hepatitis B; therefore, people with delta hepatitis have both hepatitis B and hepatitis D virus infection. Most people with hepatitis D eventually develop cirrhosis, which causes scarring and damage to the liver. There is currently no effective treatment for chronic hepatitis D. * Lonafarnib is a drug that was originally designed to treat different types of cancer. It may be able to prevent the hepatitis D virus from reproducing itself. However, it has not been tested on people with hepatitis D. Researchers want to study different doses of lonafarnib to see how they affect virus levels and other symptoms of hepatitis D. Objectives: \- To test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D. Eligibility: \- Individuals at least 18 years of age who have chronic hepatitis D. Design: * Participants will be screened with a medical history and physical exam. They will have blood and urine tests, eye exams, and imaging studies of the liver and gall bladder. A liver biopsy may also be performed. * Participants will receive either lonafarnib or placebo twice a day for 28 days. For the first 3 days, participants will stay in the hospital to have frequent blood tests. Participants will have four more clinic visits (on days 7, 14, 21, and 28) for blood and urine tests. Eye exams and heart function tests will also be given. Men may be asked to provide sperm samples for further testing. * After the 28 days of treatment, participants will stop taking the drug or placebo. They will have regular followup visits for up to 6 months after stopping treatment....

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.5 years ago

Interventions

Lonafarnibdrug

Commercially approved products used to test the research hypothesis

Placeboother

Placebo control