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

Primary Purpose

Hepatitis Delta Virus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lonafarnib
Ritonavir
PEG IFN-alfa-2a
Placebo Lonafarnib
Placebo Ritonavir
Sponsored by
Eiger BioPharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis Delta Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Fresno
  • Ruane Clinical Research Group Inc.
  • Asia Pacific Liver Center
  • Stanford University
  • University of California Davis Health System
  • Kaiser Permanente Medical Center Sacramento
  • Yale University Medical Center
  • University of Miami Schiff Center for Liver Disease
  • Rush University Medical Center
  • University of Iowa Hospitals & Clinics
  • National Institutes of Health
  • Henry Ford Health System
  • Mt. Sinai Hospital
  • NYU Langone Medical Center
  • University of Rochester Medical Center
  • Central Sooner Research
  • University of Texas Southwestern Medical Center
  • Baylor St. Luke's Medical Center
  • ZNA Stuivenberg
  • C.H.U. Brugmann
  • Cliniques Universitaires de Bruxelles Hopital Erasme
  • Universitair Ziekenhuis Antwerpen
  • CHU Sart Tilman
  • Acibadem City Clinic Tokuda Hospital Ead
  • UMHAT "Alexandrovska" EAD
  • UMHAT "Sv. Ivan Rilski", EAD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • University of Calgary
  • University Health Network
  • Toronto Liver Centre
  • McGill University Health Centre/Glen Site / Royal Victoria Hospital
  • CHU Nice - Hôpital de l'Archet 2
  • CHU Strasbourg - Hôpital Hautepierre
  • CHU Bordeaux - Hôpital Haut-Lévêque
  • Hôpital Beaujon
  • CHU de Grenoble - Hôpital Nord
  • Centre Hospitalier de la Croix Rousse
  • Hôpital Jean Verdier
  • Hôpital Paul Brousse
  • Universitaetsklinikum Freiburg
  • Universitaetsklinikum Tuebingen
  • Goethe Universität Frankfurt Am Main
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Essen
  • Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
  • Charite - Campus Virchow-Klinikum
  • Universitaetsklinikum Hamburg-Eppendorf
  • General Hospital of Athens Laiko
  • HaEmek Medical Center
  • Soroka University Medical Center
  • Rambam Health Care Center
  • The Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Galilee Medical Center
  • Chaim Sheba Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Istituto Clinico Humanitas
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • Universita di Modena e Reggio Emilia. Nuovo Ospedale civil
  • Azienda Ospedaliera Universitaria "Federico II"
  • Azienda Ospedaliero Universitaria di Parma
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • ISMP Spitalul Clinic Republican "Timofei Mosneaga"
  • Rtl Sm Srl
  • The Liver Center
  • Auckland City Hospital
  • The Aga Khan University
  • S.C MedLife S.A
  • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Institutul Clinic Fundeni
  • Fundatia "Dr. Victor Babes"
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department.
  • Krasnodar specialized clinical infectious diseases hospital
  • Modern Medicine Clinic, LLC
  • H-Clinic, LLC
  • National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation
  • Healthy Family, LLC
  • Clinica UZI 4D, LLC
  • Medical University "Reaviz"
  • Hepatolog, LLC
  • State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH
  • Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) "Yakut Republican clinical hospital"
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitari i Politecnic La Fe
  • Falu Lasarett
  • Karolinska Universitetssjukhuset Huddinge
  • Skånes Universitetssjukhus
  • Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi
  • Changhua Christian Hospital
  • Chia-Yi Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Dicle University, Medical Faculty
  • Koc University Hospital
  • Ege University Medical Faculty
  • Hospital of the state institution "National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine"
  • Medical Center "Harmony of Beauty", LLC
  • Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC
  • Medical Center "Preventclinic", LLC
  • Municipal Enterprise "Poltava Regional Clinical Infectious Hospital of Poltava Regional Council"
  • University Hospital of Sumy State University
  • Municipal non-profit enterprise " Vinnytsia city clinical hospital No. 1"
  • Royal London Hospital
  • Gartnavel General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Lonafarnib 50 mg BID + Ritonavir 100 mg BID

Lonafarnib 50 mg BID + Ritonavir 100 mg BID + PEG IFN alfa-2a 180 mcg QW

placebo Lonafarnib + placebo Ritonavir + PEG IFN-alfa-2a 180 mcg QW

placebo Lonafarnib + placebo Ritonavir

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

To compare the histologic response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo.
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.
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.
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.
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.
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.

Full Information

First Posted
October 18, 2018
Last Updated
April 13, 2023
Sponsor
Eiger BioPharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03719313
Brief Title
Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
Acronym
D-LIVR
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eiger BioPharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis Delta Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Lonafarnib 50 mg BID + Ritonavir 100 mg BID
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Lonafarnib 50 mg BID + Ritonavir 100 mg BID + PEG IFN alfa-2a 180 mcg QW
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
placebo Lonafarnib + placebo Ritonavir + PEG IFN-alfa-2a 180 mcg QW
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
placebo Lonafarnib + placebo Ritonavir
Intervention Type
Drug
Intervention Name(s)
Lonafarnib
Other Intervention Name(s)
EBP994, Sarasar, LNF
Intervention Description
Lonafarnib (LNF) 50 mg BID
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Other Intervention Name(s)
Norvir, RTV
Intervention Description
Ritonavir (RTV) 100 mg BID
Intervention Type
Drug
Intervention Name(s)
PEG IFN-alfa-2a
Other Intervention Name(s)
Pegasys, pegylated interferon-alfa
Intervention Description
PEG IFN alfa-2a 180 mcg QW
Intervention Type
Drug
Intervention Name(s)
Placebo Lonafarnib
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo Ritonavir
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UCSF Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Asia Pacific Liver Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Yale University Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3206
Country
United States
Facility Name
University of Miami Schiff Center for Liver Disease
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
National Institutes of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11016
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8857
Country
United States
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
C.H.U. Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Acibadem City Clinic Tokuda Hospital Ead
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
McGill University Health Centre/Glen Site / Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU Nice - Hôpital de l'Archet 2
City
Nice Cedex 3
State/Province
Alpes Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Strasbourg - Hôpital Hautepierre
City
Strasbourg Cedex
State/Province
Bas Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
CHU Bordeaux - Hôpital Haut-Lévêque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Beaujon
City
Clichy cedex
State/Province
Hauts De Seine
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Grenoble - Hôpital Nord
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier de la Croix Rousse
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69004
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
State/Province
Seine Saint Denis
ZIP/Postal Code
93140
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94804
Country
France
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Goethe Universität Frankfurt Am Main
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
General Hospital of Athens Laiko
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84001
Country
Israel
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52363
Country
Israel
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico G. Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Universita di Modena e Reggio Emilia. Nuovo Ospedale civil
City
Modena
ZIP/Postal Code
1355
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
ISMP Spitalul Clinic Republican "Timofei Mosneaga"
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Rtl Sm Srl
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
The Liver Center
City
Ulaanbaatar
ZIP/Postal Code
14230-0054
Country
Mongolia
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
The Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
S.C MedLife S.A
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
City
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Fundatia "Dr. Victor Babes"
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department.
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
Facility Name
Krasnodar specialized clinical infectious diseases hospital
City
Krasnodar
ZIP/Postal Code
350000
Country
Russian Federation
Facility Name
Modern Medicine Clinic, LLC
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
H-Clinic, LLC
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Healthy Family, LLC
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Clinica UZI 4D, LLC
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Medical University "Reaviz"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Hepatolog, LLC
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) "Yakut Republican clinical hospital"
City
Yakutsk
ZIP/Postal Code
677005
Country
Russian Federation
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Huddinge
ZIP/Postal Code
14157
Country
Sweden
Facility Name
Skånes Universitetssjukhus
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50004
Country
Taiwan
Facility Name
Chia-Yi Christian Hospital
City
Chia-Yi City
ZIP/Postal Code
600
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Dicle University, Medical Faculty
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Koc University Hospital
City
Istanbul
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Hospital of the state institution "National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine"
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Medical Center "Harmony of Beauty", LLC
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Medical Center "Preventclinic", LLC
City
Kyiv
ZIP/Postal Code
03035
Country
Ukraine
Facility Name
Municipal Enterprise "Poltava Regional Clinical Infectious Hospital of Poltava Regional Council"
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
University Hospital of Sumy State University
City
Sumy
ZIP/Postal Code
40000
Country
Ukraine
Facility Name
Municipal non-profit enterprise " Vinnytsia city clinical hospital No. 1"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Royal London Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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