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Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir

NCT02511431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-09-25

Study results available
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Summary

Background:

\- Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver. There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the drugs lonafarnib and ritonavir can help people with chronic hepatitis D.

Objective:

\- To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and effective.

Eligibility:

\- People 18 years of age and older with chronic hepatitis D. They must not have HIV or other major illnesses.

Design:

* Participants will be screened with medical history, physical exams, and blood tests.
* Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up.
* Participants will be in 1 of 6 treatment groups. Those in each group will receive different doses of the study drugs. Some groups will start with placebo but will receive treatment after 3 months of placebo.
* Participants will also take drugs to treat hepatitis B.
* Participants will have many visits. These will include:
* One three-day stay at the Clinical Center
* Physical exams
* EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm
* Ultrasounds of the abdomen
* Urine and blood tests
* Stool samples
* Eye exams
* Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may provide a sperm sample (optional).

Conditions

  • Hepatitis D

Interventions

DRUG

Lonafarnib

prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.

DRUG

Ritonavir

FDA approved drug for use of boosting other drugs. Will be used to boost Lonafarnib as they both use the same cytochrome P450 system. Will be administered at 100 mg daily.

OTHER

Placebo

Placebo

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2017-02-23
Completion
2017-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02511431 on ClinicalTrials.gov