Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a (D-LIVR)
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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
|
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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 |
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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Lonafarnib 50 mg BID + Ritonavir 100 mg BID
|
Drug: Lonafarnib
Lonafarnib (LNF) 50 mg BID
Other Names:
Drug: Ritonavir Ritonavir (RTV) 100 mg BID
Other Names:
|
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:
Drug: Ritonavir Ritonavir (RTV) 100 mg BID
Other Names:
Drug: PEG IFN-alfa-2a PEG IFN alfa-2a 180 mcg QW
Other Names:
|
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:
Drug: Placebo Lonafarnib Placebo Drug: Placebo Ritonavir Placebo |
Placebo Comparator: Group 4
placebo Lonafarnib + placebo Ritonavir
|
Drug: Placebo Lonafarnib
Placebo Drug: Placebo Ritonavir Placebo |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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.
Exclusion Criteria:
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.
- History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG IFN-alfa-2a, tenofovir or entecavir.

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

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. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |