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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719313
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis Delta Virus Drug: Lonafarnib Drug: Ritonavir Drug: PEG IFN-alfa-2a Drug: Placebo Lonafarnib Drug: Placebo Ritonavir Phase 3

Detailed Description:

This partially double-blind, randomized study will employ a matrix (factorial) design to evaluate the efficacy and safety of LNF 50 mg/RTV 100 mg twice per day (BID) with and without PEG IFN-alfa-2a 180 mcg once-weekly (QW) for 48 weeks compared to no treatment (placebo LNF and placebo RTV) in patients chronically infected with hepatitis delta virus (HDV) and receiving anti-HBV (hepatitis B virus) nucleos(t)ide maintenance therapy.

Approximately 400 patients will be randomized with an allocation ratio of 7:5:2:2 All patients will receive/maintain background anti-HBV nucleos(t)ide therapy with entecavir or tenofovir for at least 12 weeks prior to initiating study therapy.

All patients who complete 48 weeks of treatment will have a liver biopsy for histology assessment at EOT and will be followed for an additional 24 weeks off study treatment.

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Lonafarnib 50 mg BID + Ritonavir 100 mg BID
 Drug: Lonafarnib
Lonafarnib (LNF) 50 mg BID
Other Names:
  • EBP994
  • Sarasar
  • LNF

Drug: Ritonavir
Ritonavir (RTV) 100 mg BID
Other Names:
  • Norvir
  • RTV
Experimental: Group 2
Lonafarnib 50 mg BID + Ritonavir 100 mg BID + PEG IFN alfa-2a 180 mcg QW
 Drug: Lonafarnib
Lonafarnib (LNF) 50 mg BID
Other Names:
  • EBP994
  • Sarasar
  • LNF

Drug: Ritonavir
Ritonavir (RTV) 100 mg BID
Other Names:
  • Norvir
  • RTV

Drug: PEG IFN-alfa-2a
PEG IFN alfa-2a 180 mcg QW
Other Names:
  • Pegasys
  • pegylated interferon-alfa
Active Comparator: Group 3
placebo Lonafarnib + placebo Ritonavir + PEG IFN-alfa-2a 180 mcg QW
 Drug: PEG IFN-alfa-2a
PEG IFN alfa-2a 180 mcg QW
Other Names:
  • Pegasys
  • pegylated interferon-alfa

Drug: Placebo Lonafarnib
Placebo

Drug: Placebo Ritonavir
Placebo
Placebo Comparator: Group 4
placebo Lonafarnib + placebo Ritonavir
 Drug: Placebo Lonafarnib
Placebo

Drug: Placebo Ritonavir
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. To compare the composite virologic and biochemical response rate at end-of-treatment (EOT) in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo. [ Time Frame: 48 weeks ]
  2. To compare the composite virologic and biochemical response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. To compare the histologic response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo. [ Time Frame: 48 weeks ]
  2. To compare the histologic response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo. [ Time Frame: 48 weeks ]
  3. To evaluate the health-related quality of life (HRQL) over a 48-week treatment period in patients who receive LNF 50 mg/RTV 100 mg BID vs placebo. [ Time Frame: 48 weeks ]
  4. To evaluate the HRQL over a 48-week treatment period in patients who receive LNF 50 mg/RTV 100 mg BID/PEG IFN-alfa-2a 180 mcg QW vs placebo. [ Time Frame: 48 weeks ]
  5. To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] over a 48-week treatment period in patients who receive LNF 50 mg/RTV 100 mg BID vs placebo. [ Time Frame: 48 weeks ]
  6. To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] over a 48-week treatment period in patients who receive LNF 50 mg/RTV 100 mg BID/PEG IFN-alfa-2a 180 mcg QW vs placebo. [ Time Frame: 48 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.
  4. Baseline liver biopsy demonstrating evidence of chronic hepatitis.
  5. ECGs demonstrating no acute ischemia or clinically significant abnormality.
  6. Normal dilated retinal examination.

Exclusion Criteria:

General Exclusions

  1. Previous use of LNF within 12 months.
  2. Current or previous history of decompensated liver disease.
  3. Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable HIV RNA and HCV RNA, respectively.
  4. Evidence of significant portal hypertension.
  5. Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy.
  6. History of hepatocellular carcinoma.

  7. Patients with any of the following:

    • Current eating disorder
    • Evidence of alcohol substance use disorder.
    • Drug abuse within the previous 6 months before screening.

  8. 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.
  9. Other significant medical condition that may require intervention during the study.
  10. Any condition that may impact proper absorption.
  11. 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.
  12. Use of heparin or warfarin.
  13. Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV.
  14. Receipt of systemic immunosuppressive therapy.
  15. History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG IFN-alfa-2a, tenofovir or entecavir.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719313


Contacts
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Contact: Sue Speyer 650-272-6138 DLIVR@eigerbio.com

Locations
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United States, California
UCSF Fresno Recruiting
Fresno, California, United States, 93701
Contact: Sonia Garcia    559-459-6399    sgarcia@fresno.ucsf.edu   
Principal Investigator: Marina Roytman, Dr.         
Ruane Clinical Research Group Inc. Recruiting
Los Angeles, California, United States, 90036
Contact: Lucy Reynell    323-954-0400 ext 236    lreynell@ruaneclinicalresearch.com   
Contact: Dani Ain       dain@ruaneclinicalresearch.com   
Principal Investigator: Sergio Rojter, Dr.         
Asia Pacific Liver Center Recruiting
Los Angeles, California, United States, 90057
Contact: Mimi Chang    213-207-5793    mimichang@verity.org   
Principal Investigator: Ho Bae, Dr.         
Stanford University Recruiting
Palo Alto, California, United States, 94303
Contact: Swati Toppo    650-721-4326    stoppo@stanford.edu   
Contact: Paul Kwo, Dr.       pkwo@stanford.edu   
Principal Investigator: Paul Kwo, Dr.         
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Contact: Sandeep Dhaliwal    916-734-8696    sandhaliwal@ucdavis.edu   
Principal Investigator: Stuart Cohen, Dr.         
Kaiser Permanente Medical Center Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Renee Cunanan    916-973-4885    renee.j.cunanan@kp.org   
Principal Investigator: Chhaya P Hasyagar, Dr.         
United States, Connecticut
Yale University Medical Center Recruiting
New Haven, Connecticut, United States, 06510-3206
Contact: Hong Chau    203-785-3409    hong.chau@yale.edu   
Principal Investigator: Joseph Lim, Dr.         
United States, Florida
University of Miami Schiff Center for Liver Disease Recruiting
Miami, Florida, United States, 33136
Contact: Katheryn Dae    305-243-1104    kqd1@med.miami.edu   
Principal Investigator: Eugene Schiff, Dr.         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Diana Goldman    312-563-3919    Diana_Goldman@rush.edu   
Principal Investigator: Nancy Reau, Dr.         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jessica Valestin    319-353-4574    jessica-valestin@uiowa.edu   
Principal Investigator: Arvind Murali, Dr.         
United States, Maryland
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20814
Contact: Patient Coordinator    301-435-6121      
Principal Investigator: Christopher Koh, Dr.         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Erin Tallon    313-916-2684    etallon2@hfhs.org   
Principal Investigator: Stuart Gordon, Dr.         
United States, New York
Mt. Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Meredith Lewis    212-824-7931    meredith.lewis@mssm.edu   
Contact: Shanti Mangar    212-824-7587    shanti.mangar@mssm.edu   
Principal Investigator: Douglas Dieterich, Dr.         
NYU Langone Medical Center Recruiting
New York, New York, United States, 11016
Contact: Mary Olson    646-962-4926    Mary.Olson@nyulangone.org   
Principal Investigator: Viviana Figueroa-Diaz, Dr.         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Chelsea DiBella    585-275-0803    chelsea_dibella@urmc.rochester.edu   
Principal Investigator: Jonathan Huang, Dr.         
United States, Oklahoma
Central Sooner Research Recruiting
Norman, Oklahoma, United States, 73071
Contact: Kurt Smith    405-329-0474    ksmith@centralsooner.com   
Principal Investigator: Robert Gordon, Dr.         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8857
Contact: Debra Rowan    214-645-6126    debra.rowan@utsouthwestern.edu   
Principal Investigator: William Lee, Dr.         
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Jignesh Patel    713-798-1966    jignesh.patel@bcm.edu   
Principal Investigator: John Vierling, Dr.         
Belgium
ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Kristof Lesneuck    +32498648167    kristof.lesneuck@sgs.com   
Principal Investigator: Bourgeois, Stefan Bourgeois, Dr.         
C.H.U. Brugmann Recruiting
Bruxelles, Belgium, 1020
Contact: Daphné Benteyn    +3224773621    adeline.derodezbenavent@chu-brugmann.be   
Principal Investigator: Luc Lasser, Dr.         
Cliniques Universitaires de Bruxelles Hopital Erasme Recruiting
Bruxelles, Belgium, 1070
Contact: Nesrine Amari    +32498648167    kristof.lesneuck@sgs.com   
Principal Investigator: Christophe Moreno, Prof.         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Hannah Muylle    +3238213633    hannah.muylle@uza.be   
Principal Investigator: Thomas Vanwolleghem, Dr.         
CHU Sart Tilman Recruiting
Liège, Belgium, 4000
Contact: Sylvie Wertz    +3242844495    swertz@chuliege.be   
Principal Investigator: Jean Delwaide, Prof.         
Bulgaria
Acibadem City Clinic Tokuda Hospital Ead Recruiting
Sofia, Bulgaria, 1407
Contact: Marieta Gamzova-Kelleva    (359) 884-9331 x98    marieta.gamzova@acibademcityclinic.bg   
Principal Investigator: Rozalina Balabanska, Dr.         
UMHAT "Alexandrovska" EAD Recruiting
Sofia, Bulgaria, 1431
Contact: Nataliya Kolarova    +359 892 226 039    n.kolarova@rdservices.org   
Principal Investigator: Diana Stefanova-Petrova, Prof.         
UMHAT "Sv. Ivan Rilski", EAD Recruiting
Sofia, Bulgaria, 1431
Contact: Maria Petkova    359882401434    mdpetkovamd@abv.bg   
Principal Investigator: Krassimir Antonov, AProf.         
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Recruiting
Stara Zagora, Bulgaria, 6000
Contact: Daniela Radicheva    359887095903    d_radicheva@abv.bg   
Principal Investigator: Mariana Penkova, AProf.         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Leah Kilvert    403-220-8966    lvkilver@ucalgary.ca   
Principal Investigator: Matt Sadler, Dr.         
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Seham Noureldin    (416) 340-4800 ext 8681    Seham.Noureldin@uhnresearch.ca   
Principal Investigator: Jordan Feld, Dr.         
Toronto Liver Centre Recruiting
Toronto, Ontario, Canada, M6H 3M1
Contact: Marzena Magnes    416-652-2512    magnes.marzena8@gmail.com   
Principal Investigator: Magdy Elkhashab, Dr.         
Canada, Quebec
McGill University Health Centre/Glen Site / Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Jonathan Roger    (514) 934-1934 ext 32547    jonathan.roger@muhc.mcgill.ca   
Principal Investigator: Marc Deschenes, Dr.         
France
CHU Nice - Hôpital de l'Archet 2 Recruiting
Nice Cedex 3, Alpes Maritimes, France, 06200
Contact: Emmanuelle Mouraux    +33492039406    mouraux.e@chu-nice.fr   
Principal Investigator: Albert Tran, Prof.         
CHU Strasbourg - Hôpital Hautepierre Recruiting
Strasbourg Cedex, Bas Rhin, France, 67098
Contact: Pauline Simo-Noubissie    +33369549682    pauline.simo-noumbissie@chru-strasbourg.fr   
Principal Investigator: François Habersetzer, Dr.         
CHU Bordeaux - Hôpital Haut-Lévêque Recruiting
Pessac, Gironde, France, 33604
Contact: Paul Emmanuel Truchot    +33557656439    paul-emmanuel.truchot@chu-bordeaux.fr   
Principal Investigator: Victor De Ledinghen, Prof.         
Hôpital Beaujon Recruiting
Clichy cedex, Hauts De Seine, France, 92110
Contact: Stephanie Narguet    +33140875514    stephanie.narguet@aphp.fr   
Principal Investigator: Patrick Marcellin, Prof.         
CHU de Grenoble - Hôpital Nord Recruiting
La Tronche, Isere, France, 38043
Contact: Audrey Thoor    33476767764    athoor@chu-grenoble.fr   
Principal Investigator: Marie-Noëlle Hilleret, Dr.         
Centre Hospitalier de la Croix Rousse Recruiting
Lyon, Rhone, France, 69004
Contact: Benedicte Poumaroux    33426732737    benedicte.poumaroux@chu-lyon.fr   
Principal Investigator: Fabien Zoulim, Prof.         
Hôpital Jean Verdier Recruiting
Bondy, Seine Saint Denis, France, 93140
Contact: Severine Brule-Donneger       severine.donneger@aphp.fr   
Principal Investigator: Nathalie Ganne, Prof.         
Hôpital Paul Brousse Recruiting
Villejuif, Val De Marne, France, 94804
Contact: Sylvie Tresson    +33145593028    sylvie.tresson-ext@aphp.fr   
Principal Investigator: Didier Samuel, Prof.         
Germany
Universitaetsklinikum Freiburg Recruiting
Freiburg, Baden Wuerttemberg, Germany, 79106
Contact: Giusi Teufel    0761/270-32613    giusi.teufel@uniklinik-freiburg.de   
Principal Investigator: Christoph Neumann-Haefelin, Dr.         
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Baden Wuerttemberg, Germany, 72076
Contact: Thomas Klag    49707184457    thomas.klag@med.uni-tuebingen.de   
Principal Investigator: Christoph Berg, Prof.         
Goethe Universität Frankfurt Am Main Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Kathrin Sprinzl    4969630187687    kathrin.sprinzl@kgu.de   
Principal Investigator: Stefan Zeuzem, Prof.         
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Linda Hinneburg    5115325702    hinneburg.linda@mh-hannover.de   
Principal Investigator: Heiner Wedemeyer, Prof.         
Universitaetsklinikum Essen Recruiting
Essen, Nordrhein Westfalen, Germany, 45147
Contact: Sandra Christoph    0201-723 4410    sandra.christoph@uk-essen.de   
Principal Investigator: Gudrun Martina Hilgard, Prof.         
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH Recruiting
Berlin, Germany, 10439
Contact: Nicole Gersbacher-Runge    +49 30-948729-41    gersbacher-runge@zibp.de   
Principal Investigator: Patrick Ingiliz, Dr.         
Charite - Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Julia Benckert    (304) 505-5319 x9    julia.benckert@charite.de   
Principal Investigator: Tobias Mueller, AProf.         
Universitaetsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Contact: Kirsten Aue-Raschka       k.aue-raschka@uke.de   
Contact       j.schulze-zur-wiesch@uke.de   
Principal Investigator: Julian Schulze zur Wiesch, Dr.         
Greece
General Hospital of Athens Laiko Recruiting
Athens, Greece, 11527
Contact: Sofia Anagnostopoulou    302132061166    sopanagn@gmail.com   
Principal Investigator: George Papatheodoridis, AProf.         
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Jenia Sharav    +97226555467    genia_sh@clalit.org.il   
Principal Investigator: Rawi Hazzan, Dr.         
Soroka University Medical Center Recruiting
Beer-Sheva, Israel, 84001
Contact: Irena Kantor    +972528838849    kantorir@clalit.org.il   
Principal Investigator: Ohad Etzion, Dr.         
Rambam Health Care Center Recruiting
Haifa, Israel, 3109601
Contact: Vered Ben-Hakoun    +97248542017    v_ben-hakoon@rambam.health.gov.il   
Principal Investigator: Ella Veitsman, Dr.         
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Orly Azulay    97248250499    orlyaz@clalit.org.il   
Principal Investigator: Eli Zuckerman, Prof.         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Daniela Armoni    +97226555467    danielarmoni@szmc.org.il   
Principal Investigator: Yoav Lurie, Dr.         
Hadassah University Hospital - Ein Kerem Recruiting
Jerusalem, Israel, 9112001
Contact: Yasmin Malabi    (972) 526-3522 x87    yasminm@hadassah.org.il   
Principal Investigator: Rifaat Safadi, Dr.         
Galilee Medical Center Recruiting
Nahariya, Israel, 2210001
Contact: Nelly Bar Guy    +97249107748    nellyb@gmc.gov.il   
Principal Investigator: Nimer, Assy Nimer, Prof.         
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52363
Contact: Avishag Hassid    +97235307002    avishag.hassid@sheba.health.gov.il   
Principal Investigator: Ziv Ben Ari, Prof.         
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Rossana Fontana    390882410785    fontana_r13@yahoo.it   
Principal Investigator: Grazia Niro, Dr.         
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Rossella Meli    +39 3914515901    rossella.meli@humanitas.it   
Principal Investigator: Alessio Aghemo, Dr.         
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Recruiting
Brescia, Italy, 25123
Contact: Serena Zaltron       francesco.castelli@unibs.it   
Principal Investigator: Francesco Castelli, Prof.         
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Recruiting
Foggia, Italy, 71100
Contact: Alessandro Di Stefano       aledisti90@gmail.com   
Principal Investigator: Teresa Antonia Santantonio, Dr.         
Azienda Ospedaliera Universitaria Policlinico G. Martino Recruiting
Messina, Italy, 98124
Contact: Gaia Caccamo    390902212000    gcaccamo@unime.it   
Principal Investigator: Giovanni Raimondo, Prof.         
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Marta Borghi    +390250320378    marta-borghi@libero.it   
Principal Investigator: Pietro Lampertico, Prof.         
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Recruiting
Milano, Italy, 20162
Contact: Sara Vassalli    +390264442189    sara.vassalli@ospedaleniguarda.it   
Principal Investigator: Massimo Puoti, Dr.         
Universita di Modena e Reggio Emilia. Nuovo Ospedale civil Recruiting
Modena, Italy, 1355
Contact: Marzia Margotti    +39 (59) 396-2209    marzia.margotti@unibo.it   
Principal Investigator: Francesca Carubbi, Prof.         
Azienda Ospedaliera Universitaria "Federico II" Recruiting
Napoli, Italy, 80131
Contact: Giuseppina Brancaccio    393383738725    ggbrancaccio@gmail.com   
Principal Investigator: Giovanbattista Gaeta, Prof.         
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, Italy, 43100
Contact: Diletta Laccabue    +390521702727    dilettal@hotmail.com   
Principal Investigator: Carlo Ferrari, Dr.         
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56124
Contact: Francesca Romana Guarino    +39 050996709    francesca.guarino.frg@gmail.com   
Principal Investigator: Maurizia Rossana Brunetto, Dr.         
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Contact: Martina Milana    390672596803    martinamilana@gmail.com   
Principal Investigator: Ilaria Lenci, Dr.         
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Giulia Verzon    +39 011 6336224    verzongiulia@gmail.com   
Principal Investigator: Alessia Ciancio, Dr.         
Moldova, Republic of
ISMP Spitalul Clinic Republican "Timofei Mosneaga" Recruiting
Chisinau, Moldova, Republic of, 2025
Contact: Eugen Tcaciuc    373744649400    eugen.tcaciuc@usnf.md   
Principal Investigator: Adela Turcanu, Dr.         
Rtl Sm Srl Recruiting
Chisinau, Moldova, Republic of, MD-2025
Contact: Diana Raileanu    37369104768    raidiana29@gmail.com   
Principal Investigator: Victoria Babitchi, Dr.         
Mongolia
The Liver Center Recruiting
Ulaanbaatar, Mongolia, 14230-0054
Contact: Delgersaikhan Zulkhuu       z.delgersaikhan@onomfoundation.org   
Principal Investigator: Naranjargal Dashdorj, MD, PhD         
New Zealand
Auckland City Hospital Recruiting
Grafton, New Zealand, 1023
Contact: Faye Manu    64 9 307 4949    Fayem@adhb.govt.nz   
Principal Investigator: Edward Gane, Prof.         
Pakistan
The Aga Khan University Recruiting
Karachi, Pakistan, 74800
Contact: Paras Shahzad    +92 332 6932696    paras.shahzad@aku.edu   
Principal Investigator: Saeed Hamid, Dr.         
Romania
S.C MedLife S.A Recruiting
Bucuresti, Romania, 010719
Contact: Oana Marin    +40758110071    oana.marin@scala-cr.com   
Principal Investigator: Ion-Eugeniu Craciun, Dr.         
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Recruiting
Bucuresti, Romania, 010825
Contact: Daniel Balaban    40742519793    vbalaban@yahoo.com   
Principal Investigator: Mariana Jinga, Dr.         
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Recruiting
Bucuresti, Romania, 021105
Contact: Anca Streinu-Cercel    40722998425    anca_sc@yahoo.com   
Principal Investigator: Adrian Streinu-Cercel, Prof.         
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Recruiting
Bucuresti, Romania, 021105
Contact: Monica Radu    40722597702    drmnradu@gmail.com   
Principal Investigator: Florin Caruntu, Prof.         
Institutul Clinic Fundeni Recruiting
Bucuresti, Romania, 022328
Contact: Laura Iliescu    40722235695    laura_ate@yahoo.com   
Principal Investigator: George Stancu, Dr.         
Institutul Clinic Fundeni Recruiting
Bucuresti, Romania, 022328
Principal Investigator: Liliana Simona Gheorghe, AProf.         
Fundatia "Dr. Victor Babes" Recruiting
Bucuresti, Romania, 030303
Contact: Madalina Neata    +40746097986    mada_becheru@yahoo.com   
Principal Investigator: George Sebastian Gherlan, Dr.         
Spitalul Clinic Judetean de Urgenta Cluj Napoca Recruiting
Cluj-Napoca, Romania, 400006
Contact: David Liliana    (407) 422-0496 x3    lilidavid2007@yahoo.com   
Principal Investigator: Dan Lucian Dumitrascu, Prof.         
Russian Federation
Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department. Recruiting
Chelyabinsk, Russian Federation, 454052
Contact: Olga Sagalova    79128955378    Olga_sagalova@mail.ru   
Principal Investigator: Olga Sagalova         
Krasnodar specialized clinical infectious diseases hospital Recruiting
Krasnodar, Russian Federation, 350000
Contact: Sergey Zotov    +7 988 243 41 49    S.V.Zotov@mail.ru   
Principal Investigator: Viktoria Bakhtina         
Modern Medicine Clinic, LLC Recruiting
Moscow, Russian Federation, 121170
Contact: Tatiana Stepanova    79067937122    tvstepa@list.ru   
Principal Investigator: Tatiana Stepanova         
H-Clinic, LLC Recruiting
Moscow, Russian Federation, 127083
Contact: Natalia Voronkova    79104439528    voronkova@h-clinic.ru   
Principal Investigator: Natalia Voronkova         
National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation Not yet recruiting
Moscow, Russian Federation, 127473
Contact: Nina Mamonova    +7 916 744 57 81    nina.mamonova@mail.ru   
Principal Investigator: Vladimir Chulanov         
Healthy Family, LLC Recruiting
Novosibirsk, Russian Federation, 630099
Contact: Alena Abramenko    +7 923 230 29 80    lomovaav@ya.ru   
Principal Investigator: Natalia Voloshina         
Clinica UZI 4D, LLC Recruiting
Pyatigorsk, Russian Federation, 357502
Contact: Irina Verbitskaya    +7 928 904 32 30    verbitckaya2010@yandex.ru   
Principal Investigator: Daria Saenko         
Medical University "Reaviz" Recruiting
Samara, Russian Federation, 443011
Contact: Olga Arkhangelskaya    +7 927 26 200 14    arolgav@outlook.com   
Principal Investigator: Elena Bunkova         
Hepatolog, LLC Recruiting
Samara, Russian Federation, 443063
Contact: Elena Zharkova    +7 917 167 67 71    ev.zharkova@mail.ru   
Principal Investigator: Viacheslav Morozov         
State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH Recruiting
Stavropol, Russian Federation, 355017
Contact: Andrey Lipov    +7 928 650 72 64    andrey_lipov89@mail.ru   
Principal Investigator: Natalia Geyvandova         
Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) "Yakut Republican clinical hospital" Not yet recruiting
Yakutsk, Russian Federation, 677005
Contact: Olga Zamorschikova    79248664195    olya-botty@mail.ru   
Principal Investigator: Snezhana Sleptsova         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Nieves Palomo    +34932746000EXT6562    mnieves.merchan@gmail.com   
Principal Investigator: Maria Buti Ferret, Dr.         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Laura Viton    +34912071876    laura.ucicec@gmail.com   
Principal Investigator: Javier Garcia Samaniego Rey, Dr.         
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Almudena Cubells Garcia    +34961244000    almudena_cubells@iislafe.es   
Principal Investigator: Maria Garcia Eliz, Dr.         
Sweden
Falu Lasarett Recruiting
Falun, Sweden, 79182
Contact: Jessika Wikblom    4623492971    jessica.wikblom@regiondalarna.se   
Principal Investigator: Anna-Karin Jonsson, Dr.         
Karolinska Universitetssjukhuset Huddinge Recruiting
Huddinge, Sweden, 14157
Contact: Susanne Cederberg    +46 8 585 813 58    susanne.cederberg@karolinska.se   
Principal Investigator: Soo Aleman, Dr.         
Skånes Universitetssjukhus Recruiting
Malmö, Sweden, 205 02
Contact: Louise Qvist    +4646175334    louise.qvist@med.lu.se   
Principal Investigator: Leo Flamholc, Dr.         
Switzerland
Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi Recruiting
Bern, Switzerland, 3010
Contact: Kathrin Husi    +41316325933    kathrin.husi@insel.ch   
Principal Investigator: Nasser Semmo, Prof.         
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 50004
Contact: Ning-Ying Chiang    +88647238595 x3245    jenny.chiang@ttmcsmo.com   
Principal Investigator: Wei-Wen Su, Dr.         
Chia-Yi Christian Hospital Recruiting
Chia-Yi City, Taiwan, 600
Contact: Chia-Yi Chen    (886) 527-6504 xext2535    cych12497@gmail.com   
Principal Investigator: Chi-Yi Chen, Dr.         
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Hsin-Ting Chuang    +88673121101 x6770    shinkansen0301@gmail.com   
Principal Investigator: Wan-Long Chuang, Dr.         
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 824
Contact: Chiu-Jung Chen    +88677317123 x2446    cjc2446@yahoo.com.tw   
Principal Investigator: Tsung-Hui Hu, Dr.         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Chia Chi Chien    +886228712121 x3219    jenice.chien@gmail.com   
Principal Investigator: Chien-Wei Su, Dr.         
Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan County, Taiwan, 333
Contact: Yi-Meng Chiang    +88633281200 x2222    bluejiang1976@gmail.com   
Principal Investigator: Yi-Cheng Chen, Dr.         
Turkey
Dicle University, Medical Faculty Recruiting
Diyarbakir, Turkey, 21280
Contact: Necla Aytekin    5061377855    necla.aytekin@medismart.com.tr   
Principal Investigator: Mustafa Kemal Celen, Prof.         
Koc University Hospital Recruiting
Istanbul, Turkey
Contact: Ozgun Gokmen    905498231577    ogokmen@kuh.ku.edu.tr   
Principal Investigator: Cihan Yurhadin, Dr.         
Ege University Medical Faculty Recruiting
Izmir, Turkey, 35100
Contact: Aysegul Kozak    +905066318382    aysegul.kozak@medex-smo.com   
Principal Investigator: Ulus Akarca, Prof.         
Ukraine
Hospital of the state institution "National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine" Recruiting
Kharkiv, Ukraine, 61039
Contact: Inna Riabovol    380667166490    Riabovolinna@gmail.com   
Principal Investigator: Kolesnikova Vadymivna         
Medical Center "Harmony of Beauty", LLC Recruiting
Kyiv, Ukraine, 01135
Contact: Valentyn Moskalenko    38 066 941 1231    valentyn.moskalenko@arensia-em.com   
Principal Investigator: Anastasiy Anatoliyevych         
Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC Recruiting
Kyiv, Ukraine, 02091
Contact: Lesia Petryk    38 067 813 79 75    lesia.petryk@okclinic.com.ua   
Principal Investigator: Tsarynna Petrivna         
Medical Center "Preventclinic", LLC Recruiting
Kyiv, Ukraine, 03035
Contact: Vladyslava Malieieva    +38 067 999 37 31    Docmva87@gmail.com   
Principal Investigator: Barna Mykolaivna         
Municipal Enterprise "Poltava Regional Clinical Infectious Hospital of Poltava Regional Council" Recruiting
Poltava, Ukraine, 36011
Contact: Tetiana Koval    +38 050 662 38 02    kovalti@ukr.net   
Principal Investigator: Koval Ihorivna         
University Hospital of Sumy State University Recruiting
Sumy, Ukraine, 40000
Contact: Artem Horbachevskyi    + 38 068 540 85 62    a.horbachevskyi@kinf.sumdu.edu.ua   
Principal Investigator: Chemych Dmytrovych         
Municipal non-profit enterprise " Vinnytsia city clinical hospital No. 1" Recruiting
Vinnytsia, Ukraine, 21029
Contact: Svitlana Kulias    38 096 368 11 83    snk.vinn@gmail.com   
Principal Investigator: Moroz Vasylivna         
United Kingdom
Royal London Hospital Recruiting
London, Greater London, United Kingdom, E1 1BB
Contact: Louise Payaniandy    +442034165000    louise.payaniandy2@bartshealth.nhs.uk   
Principal Investigator: Patrick Kennedy, Dr.         
Gartnavel General Hospital Recruiting
Glasgow, Strathclyde, United Kingdom, G12 0YN
Contact: Kate Ocker    +441412113261    kate.ocker@ggc.scot.nhs.uk   
Principal Investigator: Erica Peters, Dr.         
Sponsors and Collaborators
Eiger BioPharmaceuticals
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT03719313    
Other Study ID Numbers: EIG-LNF-011
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis D
Hepatitis
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Infections
Interferons
Ritonavir
Interferon-alpha
Peginterferon alfa-2a
Interferon alpha-2
Lonafarnib
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs