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Trial record 6 of 21 for:    hepatitis Delta, hepatitis delta virus, HDV | Hepatitis D

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 : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

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.


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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 : April 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

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




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 ]


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.


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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.

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: John Ferraro 650-272-6138 DLIVR@eigerbio.com

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Locations
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United States, California
UCSF Fresno Not yet recruiting
Fresno, California, United States, 93701
Contact: Sonia Garcia       sgarcia@fresno.ucsf.edu   
Principal Investigator: Marina Roytman, Dr.         
Ruane Clinical Research Group Inc. Not yet 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 Not yet recruiting
Los Angeles, California, United States, 90057
Contact: Mimi Chang    213-207-5793    mimichang@verity.org   
Principal Investigator: Ho Bae, Dr.         
Stanford University Not yet recruiting
Palo Alto, California, United States, 94303
Contact: Angela Fuller       ajfuller@stanford.edu   
Principal Investigator: Paul Kwo, Dr.         
University of California Davis Health System Not yet 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 Not yet recruiting
Sacramento, California, United States, 95825
Contact: Rhonda Gage         
Contact    (913) 973-5000    rhonda.e.gage@kp.org   
Principal Investigator: Chhaya P Hasyagar, Dr.         
Southern California Permanente Medical Group Not yet recruiting
San Diego, California, United States, 92154
Contact: Vivian Soto-Zepeda    619-662-5311    vivian.soto-zepeda@kp.org   
Principal Investigator: Heather Patton, Dr.         
United States, Connecticut
Yale University Medical Center Not yet 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 Medcial Center Not yet recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Nancy Reau, Dr.         
United States, Maryland
National Institutes of Health Not yet recruiting
Bethesda, Maryland, United States, 20814
Contact    301-435-6121      
Principal Investigator: Christopher Koh, Dr.         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Joanne Dupuis    313-916-1962    Jdupuis3@hfhs.org   
Principal Investigator: Stuart Gordon, Dr.         
United States, New York
Mt. Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Meredith Lewis    212-824-7931    meredith.lewis@mssm.edu   
Principal Investigator: Douglas Dieterich, Dr.         
NYU Langone Medical Center Not yet recruiting
New York, New York, United States, 11016
Contact: Mary Olson    646-962-4742    Mary.Olson@nyulangone.org   
Principal Investigator: Viviana Figueroa-Diaz, Dr.         
University of Rochester Medical Center Not yet 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 Not yet recruiting
Dallas, Texas, United States, 75390-8857
Principal Investigator: William Lee, Dr.         
Baylor St. Luke's Medical Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jignesh Patel    713-798-1966    jignesh.patel@bcm.edu   
Principal Investigator: John Vierling, Dr.         
Belgium
ZNA Stuivenberg Not yet recruiting
Antwerpen, Belgium, 2060
Principal Investigator: Bourgeois, Stefan Bourgeois, Dr.         
C.H.U. Brugmann Not yet recruiting
Bruxelles, Belgium, 1020
Principal Investigator: Luc Lasser, Dr.         
Cliniques Universitaires de Bruxelles Hopital Erasme Not yet recruiting
Bruxelles, Belgium, 1070
Principal Investigator: Christophe Moreno, Prof.         
Universitair Ziekenhuis Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Principal Investigator: Thomas Vanwolleghem, Dr.         
CHU Sart Tilman Not yet recruiting
Liège, Belgium, 4000
Principal Investigator: Jean Delwaide, Prof.         
Bulgaria
Acibadem City Clinic Tokuda Hospital Ead Not yet recruiting
Sofia, Bulgaria, 1407
Principal Investigator: Rozalina Balabanska, Dr.         
UMHAT "Alexandrovska" EAD Not yet recruiting
Sofia, Bulgaria, 1431
Principal Investigator: Diana Stefanova-Petrova, Prof.         
UMHAT "Sv. Ivan Rilski", EAD Not yet recruiting
Sofia, Bulgaria, 1431
Principal Investigator: Krassimir Antonov, AProf.         
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Not yet recruiting
Stara Zagora, Bulgaria, 6000
Principal Investigator: Mariana Penkova, AProf.         
Canada, Alberta
University of Calgary Not yet 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 Not yet 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 Not yet recruiting
Toronto, Ontario, Canada, M6H 3M1
Contact: Muhammad Mahmood    416-652-2512      
Principal Investigator: Magdy Elkhashab, Dr.         
Canada, Quebec
McGill University Health Centre/Glen Site / Royal Victoria Hospital Not yet 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 Not yet recruiting
Nice Cedex 3, Alpes Maritimes, France, 06200
Principal Investigator: Albert Tran, Prof.         
CHU Strasbourg - Hôpital Hautepierre Not yet recruiting
Strasbourg Cedex, Bas Rhin, France, 67098
Principal Investigator: François Habersetzer, Dr.         
CHU Bordeaux - Hôpital Haut-Lévêque Not yet recruiting
Pessac, Gironde, France, 33604
Principal Investigator: Victor De Ledinghen, Prof.         
Hôpital Beaujon Not yet recruiting
Clichy cedex, Hauts De Seine, France, 92110
Principal Investigator: Patrick Marcellin, Prof.         
CHU de Grenoble - Hôpital Nord Not yet recruiting
Grenoble cedex 9, Isere, France, 38043
Principal Investigator: Vincent Leroy, Prof.         
Centre Hospitalier de la Croix Rousse Not yet recruiting
Lyon, Rhone, France, 69004
Principal Investigator: Fabien Zoulim, Prof.         
Hôpital Paul Brousse Not yet recruiting
Villejuif, Val De Marne, France, 94804
Principal Investigator: Didier Samuel, Prof.         
Germany
Universitaetsklinikum Freiburg Not yet recruiting
Freiburg, Baden Wuerttemberg, Germany, 79106
Principal Investigator: Christoph Neumann-Haefelin, Dr.         
Universitaetsklinikum Tuebingen Not yet recruiting
Tuebingen, Baden Wuerttemberg, Germany, 72076
Principal Investigator: Christoph Berg, Prof.         
Klinikum der Johann Wolfgang Goethe-Universitaet Not yet recruiting
Frankfurt, Hessen, Germany, 60590
Principal Investigator: Tania Welzel, Prof.         
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Principal Investigator: Markus Cornberg, Prof.         
Center for HIV and Hepatogastroenterology Not yet recruiting
Düsseldorf, Nordrhein Westfalen, Germany, 40237
Principal Investigator: Stefan Mauss, Dr.         
Universitaetsklinikum Essen Not yet recruiting
Essen, Nordrhein Westfalen, Germany, 45147
Principal Investigator: Heiner Wedemeyer, Prof.         
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH Not yet recruiting
Berlin, Germany, 10439
Principal Investigator: Patrick Ingiliz, Dr.         
EPIMED- Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Not yet recruiting
Berlin, Germany, 12157
Principal Investigator: Keikawus Arastéh, Dr.         
Charite - Campus Virchow-Klinikum Not yet recruiting
Berlin, Germany, 13353
Principal Investigator: Tobias Mueller, AProf.         
Universitaetsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Principal Investigator: Julian Schulze zur Wiesch, Dr.         
Greece
General Hospital of Athens Laiko Not yet recruiting
Athens, Greece, 11527
Principal Investigator: George Papatheodoridis, AProf.         
Israel
HaEmek Medical Center Not yet recruiting
Afula, Israel, 18101
Principal Investigator: Rawi Hazzan, Dr.         
Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel, 84001
Principal Investigator: Ohad Etzion, Dr.         
Rambam Health Care Center Not yet recruiting
Haifa, Israel, 3109601
Principal Investigator: Ella Veitsman, Dr.         
The Lady Davis Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Principal Investigator: Eli Zuckerman, Prof.         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Principal Investigator: Yoav Lurie, Dr.         
Hadassah University Hospital - Ein Kerem Not yet recruiting
Jerusalem, Israel, 9112001
Principal Investigator: Rifaat Safadi, Dr.         
Galilee Medical Center Not yet recruiting
Nahariya, Israel, 2210001
Principal Investigator: Nimer, Assy Nimer, Prof.         
Chaim Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52363
Principal Investigator: Ziv Ben Ari, Prof.         
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Principal Investigator: Grazia Niro, Dr.         
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Milano, Italy, 20089
Principal Investigator: Alessio Aghemo, Dr.         
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Not yet recruiting
Bologna, Italy, 40138
Principal Investigator: Pietro Andreone, Prof.         
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Not yet recruiting
Brescia, Italy, 25123
Principal Investigator: Francesco Castelli, Prof.         
Azienda Ospedaliera S. Anna e S. Sebastiano Not yet recruiting
Caserta, Italy, 81100
Principal Investigator: Nicola Coppola, Dr.         
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Not yet recruiting
Foggia, Italy, 71100
Principal Investigator: Teresa Antonia Santantonio, Dr.         
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Not yet recruiting
Milano, Italy, 20122
Principal Investigator: Pietro Lampertico, Prof.         
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Not yet recruiting
Milano, Italy, 20162
Principal Investigator: Massimo Puoti, Dr.         
Universita di Modena e Reggio Emilia. Nuovo Ospedale civil Not yet recruiting
Modena, Italy, 1355
Principal Investigator: Pietro Andreone, Prof.         
Azienda Ospedaliera Universitaria "Federico II" Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Giovanbattista Gaeta, Prof.         
Azienda Ospedaliero Universitaria di Parma Not yet recruiting
Parma, Italy, 43100
Principal Investigator: Carlo Ferrari, Dr.         
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56124
Principal Investigator: Maurizia Rossana Brunetto, Dr.         
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Not yet recruiting
Roma, Italy, 00133
Principal Investigator: Mario Angelico,, Prof.         
Azienda Ospedaliera Città della Salute e della Scienza di Torino Not yet recruiting
Torino, Italy, 10126
Principal Investigator: Alessia Ciancio, Dr.         
Moldova, Republic of
ISMP Spitalul Clinic Republican "Timofei Mosneaga" Not yet recruiting
Chisinau, Moldova, Republic of, 2025
Principal Investigator: Adela Turcanu, Dr.         
Rtl Sm Srl Not yet recruiting
Chisinau, Moldova, Republic of, MD-2025
Principal Investigator: Victoria Babitchi, Dr.         
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 Not yet recruiting
Karachi, Pakistan, 74800
Principal Investigator: Saeed Hamid, Dr.         
Romania
S.C MedLife S.A Not yet recruiting
Bucuresti, Romania, 010719
Principal Investigator: Ion-Eugeniu Craciun, Dr.         
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Not yet recruiting
Bucuresti, Romania, 010825
Principal Investigator: Mariana Jinga, Dr.         
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Not yet recruiting
Bucuresti, Romania, 021105
Principal Investigator: Adrian Streinu-Cercel, Prof.         
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Not yet recruiting
Bucuresti, Romania, 021105
Principal Investigator: Florin Caruntu, Prof.         
Institutul Clinic Fundeni Not yet recruiting
Bucuresti, Romania, 022328
Principal Investigator: George Stancu, Dr.         
Institutul Clinic Fundeni Not yet recruiting
Bucuresti, Romania, 022328
Principal Investigator: Liliana Simona Gheorghe, AProf.         
Fundatia "Dr. Victor Babes" Not yet recruiting
Bucuresti, Romania, 030303
Principal Investigator: George Sebastian Gherlan, Dr.         
Spitalul Clinic Judetean de Urgenta Cluj Napoca Not yet recruiting
Cluj-Napoca, Romania, 400006
Principal Investigator: Dan Lucian Dumitrascu, Prof.         
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara Not yet recruiting
Timisoara, Romania, 300310
Principal Investigator: Manuela Gabriela Curescu, Prof.         
Spain
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Principal Investigator: Maria Buti Ferret, Dr.         
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Principal Investigator: Javier Garcia Samaniego Rey, Dr.         
Hospital Universitari i Politecnic La Fe Not yet recruiting
Valencia, Spain, 46026
Principal Investigator: Maria Garcia Eliz, Dr.         
Switzerland
Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi Not yet recruiting
Bern, Switzerland, 3010
Principal Investigator: Nasser Semmo, Prof.         
Taiwan
Changhua Christian Hospital Not yet recruiting
Changhua, Taiwan, 50004
Principal Investigator: Wei-Wen Su, Dr.         
Chia-Yi Christian Hospital Not yet recruiting
Chia-Yi City, Taiwan, 600
Principal Investigator: Chi-Yi Chen, Dr.         
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 807
Principal Investigator: Wan-Long Chuang, Dr.         
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 824
Principal Investigator: Tsung-Hui Hu, Dr.         
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Principal Investigator: Pei-Jer Chen, Dr.         
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
Principal Investigator: Chien-We Su, Dr.         
Chang Gung Memorial Hospital, Linkou Not yet recruiting
Taoyuan County, Taiwan, 333
Principal Investigator: Yi-Cheng Chen, Dr.         
Turkey
Dicle University, Medical Faculty Not yet recruiting
Diyarbakir, Turkey, 21280
Principal Investigator: Mustafa Kemal Celen, Prof.         
Koc University Hospital Not yet recruiting
Istanbul, Turkey
Principal Investigator: Cihan Yurhadin, Dr.         
Ege University Medical Faculty Not yet recruiting
Izmir, Turkey, 35100
Principal Investigator: Ulus Akarca, Prof.         
United Kingdom
Royal London Hospital Not yet recruiting
London, Greater London, United Kingdom, E1 1BB
Principal Investigator: Patrick Kennedy, Dr.         
Gartnavel General Hospital Not yet recruiting
Glasgow, Strathclyde, United Kingdom, G12 0YN
Principal Investigator: Erica Peters, Dr.         
Vietnam
108 Militaory Central Hospital Not yet recruiting
Hanoi, Vietnam
Principal Investigator: Song Le, Dr.         
Sponsors and Collaborators
Eiger BioPharmaceuticals

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Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT03719313     History of Changes
Other Study ID Numbers: EIG-LNF-011
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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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
Hepatitis D
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Interferons
Interferon alpha-2
Ritonavir
Interferon-alpha
Peginterferon alfa-2a
Lonafarnib
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV 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