A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR)
Who is this study for? Patients chronically infected with hepatitis delta virus and receiving anti-hepatitis B virus nucleos(t)ide maintenance therapy
Status: Completed
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UCSF Fresno
Fresno
Asia Pacific Liver Center
Los Angeles
Ruane Clinical Research Group Inc.
Los Angeles
Stanford University
Palo Alto
Kaiser Permanente Medical Center Sacramento
Sacramento
University of California Davis Health System
Sacramento
Connecticut
Yale University Medical Center
New Haven
Florida
University of Miami Schiff Center for Liver Disease
Miami
Iowa
University of Iowa Hospitals & Clinics
Iowa City
Illinois
Rush University Medical Center
Chicago
Maryland
National Institutes of Health
Bethesda
Michigan
Henry Ford Health System
Detroit
New York
Mt. Sinai Hospital
New York
NYU Langone Medical Center
New York
University of Rochester Medical Center
Rochester
Oklahoma
Central Sooner Research
Norman
Texas
University of Texas Southwestern Medical Center
Dallas
Baylor St. Luke's Medical Center
Houston
Other Locations
Belgium
ZNA Stuivenberg
Antwerpen
C.H.U. Brugmann
Bruxelles
Cliniques Universitaires de Bruxelles Hopital Erasme
Bruxelles
Universitair Ziekenhuis Antwerpen
Edegem
CHU Sart Tilman
Liège
Bulgaria
Acibadem City Clinic Tokuda Hospital Ead
Sofia
UMHAT Alexandrovska EAD
Sofia
UMHAT Sv. Ivan Rilski, EAD
Sofia
Medical Center Nov Rehabilitatsionen Tsentar, EOOD
Stara Zagora
Canada
University of Calgary
Calgary
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal
Toronto Liver Centre
Toronto
University Health Network
Toronto
France
Hôpital Jean Verdier
Bondy
Hôpital Beaujon
Clichy Cedex
CHU de Grenoble - Hôpital Nord
La Tronche
Centre Hospitalier de la Croix Rousse
Lyon
CHU Nice - Hôpital de l'Archet 2
Nice Cedex 3
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac
CHU Strasbourg - Hôpital Hautepierre
Strasbourg Cedex
Hôpital Paul Brousse
Villejuif
Germany
Charite - Campus Virchow-Klinikum
Berlin
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin
Universitaetsklinikum Essen
Essen
Goethe Universität Frankfurt Am Main
Frankfurt
Universitaetsklinikum Freiburg
Freiburg
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hannover
Universitaetsklinikum Tuebingen
Tuebingen
Greece
General Hospital of Athens Laiko
Athens
Israel
HaEmek Medical Center
Afula
Soroka University Medical Center
Beer-sheva
Rambam Health Care Center
Haifa
The Lady Davis Carmel Medical Center
Haifa
Hadassah University Hospital - Ein Kerem
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Galilee Medical Center
Nahariya
Chaim Sheba Medical Center
Ramat Gan
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milano
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano
Universita di Modena e Reggio Emilia. Nuovo Ospedale civil
Modena
Azienda Ospedaliera Universitaria Federico II
Napoli
Azienda Ospedaliero Universitaria di Parma
Parma
Azienda Ospedaliero Universitaria Pisana
Pisa
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma
Istituto Clinico Humanitas
Rozzano
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino
Mongolia
The Liver Center
Ulaanbaatar
New Zealand
Auckland City Hospital
Grafton
Pakistan
The Aga Khan University
Karachi
Republic of Moldova
ISMP Spitalul Clinic Republican Timofei Mosneaga
Chisinau
Rtl Sm Srl
Chisinau
Romania
Fundatia Dr. Victor Babes
Bucuresti
Institutul Clinic Fundeni
Bucuresti
Institutul National de Boli Infectioase Prof. Dr. Matei Bals
Bucuresti
S.C MedLife S.A
Bucuresti
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucuresti
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-napoca
Russian Federation
Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department.
Chelyabinsk
Krasnodar specialized clinical infectious diseases hospital
Krasnodar
H-Clinic, LLC
Moscow
Modern Medicine Clinic, LLC
Moscow
National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation
Moscow
Healthy Family, LLC
Novosibirsk
Clinica UZI 4D, LLC
Pyatigorsk
Hepatolog, LLC
Samara
Medical University Reaviz
Samara
State Budgetary Educational Institution of Higher Profesional Education Stavropol State Medical University of MoH
Stavropol
Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) Yakut Republican clinical hospital
Yakutsk
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Universitari i Politecnic La Fe
Valencia
Sweden
Falu Lasarett
Falun
Karolinska Universitetssjukhuset Huddinge
Huddinge
Skånes Universitetssjukhus
Malmö
Switzerland
Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi
Bern
Taiwan
Changhua Christian Hospital
Changhua
Chia-Yi Christian Hospital
Chia-yi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan County
Turkey
Dicle University, Medical Faculty
Diyarbakir
Koc University Hospital
Istanbul
Ege University Medical Faculty
Izmir
Ukraine
Hospital of the state institution National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine
Kharkiv
Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC
Kyiv
Medical Center Harmony of Beauty, LLC
Kyiv
Medical Center Preventclinic, LLC
Kyiv
Municipal Enterprise Poltava Regional Clinical Infectious Hospital of Poltava Regional Council
Poltava
University Hospital of Sumy State University
Sumy
Municipal non-profit enterprise Vinnytsia city clinical hospital No. 1
Vinnytsia
United Kingdom
Gartnavel General Hospital
Glasgow
Royal London Hospital
London
Time Frame
Start Date: 2018-12-01
Completion Date: 2023-03-24
Participants
Target number of participants: 407
Treatments
Experimental: Group 1
Lonafarnib 50 mg BID + Ritonavir 100 mg BID
Experimental: Group 2
Lonafarnib 50 mg BID + Ritonavir 100 mg BID + PEG IFN alfa-2a 180 mcg QW
Active_comparator: Group 3
placebo Lonafarnib + placebo Ritonavir + PEG IFN-alfa-2a 180 mcg QW
Placebo_comparator: Group 4
placebo Lonafarnib + placebo Ritonavir
Authors
Julian Schulze zur Wiesch, Charles Landis, Heather Patton, Christopher Koh, Ho Bae, Sergio Rojter, Marina Roytman, Nancy Reau, Stuart Cohen, Douglas Dieterich, John Vierling, Eugene Schiff, Paul Kwo, Jonathan Huang, Saeed Hamid, Viviana Figueroa-Diaz, Chhaya P Hasyagar, Victor De Ledinghen, Katja Deterding, Patrick Ingiliz, Patrick Marcellin, Heiner Wedemeyer, Markus Cornberg, Fabien Zoulim, Albert Tran, Stefan Zeuzem, Keikawus Arastéh, Stefan Mauss, Christoph Neumann-Haefelin, Tania Welzel, François Habersetzer, Vincent Leroy, Christoph Berg, Leo Flamholc, Snezhana Sleptsova, Manuela Gabriela Curescu, Yoav Lurie, Florin Caruntu, Grazia Niro, Luc Lasser, Eli Zuckerman, Ilaria Lenci, Magdy Elkhashab, Ella Veitsman, Ulus Akarca, Giovanni Raimondo, Erica Peters, Mario Angelico, Olga Sagalova, George Papatheodoridis, Soo Aleman, Pietro Lampertico, Chien-Wei Su, Nicola Coppola, Naranjargal Dashdorj, Vladimir Chulanov, Francesco Castelli, Carlo Ferrari, Rawi Hazzan, Ziv Ben Ari, Teresa Antonia Santantonio, Nasser Semmo, Wei-Wen Su, Wan-Long Chuang, Adrian Streinu-Cercel, Edward Gane, Alessia Ciancio, Tobias Mueller, Nathalie Ganne, Rifaat Safadi, George Sebastian Gherlan, Didier Samuel, Maurizia Rossana Brunetto, Liliana Simona Gheorghe, Pietro Andreone, Massimo Puoti, Marie-Noëlle Hilleret, Thomas Vanwolleghem, Alessio Aghemo, Dan Lucian Dumitrascu, Mustafa Kemal Celen, Christophe Moreno, Pei-Jer Chen, Viacheslav Morozov, Jean Delwaide, Marc Deschenes
Related Therapeutic Areas
Sponsors
Leads: Eiger BioPharmaceuticals