Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis Delta Virus

In brief

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

Key facts

Study ID

NCT03719313

Run by

Eiger BioPharmaceuticals

People needed

407

Starts

2018-12-01

Expected to finish

2023-03-24

Last updated by the study team

2023-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HDV infection for at least 6 months in duration, documented by a positive HDV antibody test and HDV RNA ≥ 500 IU/mL.
• Note: All genotypes of HDV permitted.
• Demonstrable suppression of HBV DNA following at least 12 weeks of anti-HBV nucleos(t)ide treatment with entecavir or tenofovir prior to initiating therapy.
• Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.
• Baseline liver biopsy demonstrating evidence of chronic hepatitis.
• ECGs demonstrating no acute ischemia or clinically significant abnormality.
• Normal dilated retinal examination.

You may not qualify if…

• General Exclusions
• Previous use of LNF within 12 months.
• Current or previous history of decompensated liver disease.
• Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable HIV RNA and HCV RNA, respectively.
• Evidence of significant portal hypertension.
• Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy.
• History of hepatocellular carcinoma.
• Patients with any of the following:
• Current eating disorder
• Evidence of alcohol substance use disorder.
• Drug abuse within the previous 6 months before screening.
• Prior history or current evidence of any of the following:
• Immunologically mediated disease,
• Retinal disorder or clinically relevant ophthalmic disorder,
• Any malignancy within 5 years before screening,
• Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease,
• Chronic pulmonary disease,
• Pancreatitis or colitis,
• Severe or uncontrolled psychiatric disorder.
• Other significant medical condition that may require intervention during the study.
• Any condition that may impact proper absorption.
• Therapy with an immunomodulatory agent, IFN-α (eg, IFN alfa-2a or IFN-alfa-2b, or pegylated IFN-alfa-2a or alfa 2b), cytotoxic agent, or chronic systemic corticosteroids within 12 months of screening.
• Use of heparin or warfarin.
• Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV.
• Receipt of systemic immunosuppressive therapy.

Where it is running

• Ruane Clinical Research Group Inc. — Los Angeles, California, United States
• Asia Pacific Liver Center — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California Davis Health System — Sacramento, California, United States
• Kaiser Permanente Medical Center Sacramento — Sacramento, California, United States
• Yale University Medical Center — New Haven, Connecticut, United States
• University of Miami Schiff Center for Liver Disease — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• National Institutes of Health — Bethesda, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mt. Sinai Hospital — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Central Sooner Research — Norman, Oklahoma, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• ZNA Stuivenberg — Antwerp, Belgium
• C.H.U. Brugmann — Brussels, Belgium
• Cliniques Universitaires de Bruxelles Hopital Erasme — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• CHU Sart Tilman — Liège, Belgium
• Acibadem City Clinic Tokuda Hospital Ead — Sofia, Bulgaria
• UMHAT "Alexandrovska" EAD — Sofia, Bulgaria
• UCSF Fresno — Fresno, California, United States

Full record on ClinicalTrials.gov

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