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

PHASE3CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

December 1, 2018

Primary Completion Date

October 6, 2022

Study Completion Date

March 24, 2023

Conditions
Hepatitis Delta Virus
Interventions
DRUG

Lonafarnib

Lonafarnib (LNF) 50 mg BID

DRUG

Ritonavir

Ritonavir (RTV) 100 mg BID

DRUG

PEG IFN-alfa-2a

PEG IFN alfa-2a 180 mcg QW

DRUG

Placebo Lonafarnib

Placebo

DRUG

Placebo Ritonavir

Placebo

Trial Locations (116)

333

Chang Gung Memorial Hospital, Linkou, Taoyuan

600

Chia-Yi Christian Hospital, Chia-Yi City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

824

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

1020

C.H.U. Brugmann, Brussels

1023

Auckland City Hospital, Grafton

1070

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

1355

Universita di Modena e Reggio Emilia. Nuovo Ospedale civil, Modena

1407

Acibadem City Clinic Tokuda Hospital Ead, Sofia

1431

"UMHAT Alexandrovska EAD", Sofia

"UMHAT Sv. Ivan Rilski, EAD", Sofia

2025

"ISMP Spitalul Clinic Republican Timofei Mosneaga", Chisinau

2060

ZNA Stuivenberg, Antwerp

2650

Universitair Ziekenhuis Antwerpen, Edegem

3010

Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi, Bern

4000

CHU Sart Tilman, Liège

6000

"Medical Center Nov Rehabilitatsionen Tsentar, EOOD", Stara Zagora

10029

Mt. Sinai Hospital, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

10439

Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH, Berlin

11016

NYU Langone Medical Center, New York

11217

Taipei Veterans General Hospital, Taipei

11527

General Hospital of Athens Laiko, Athens

13353

Charite - Campus Virchow-Klinikum, Berlin

14157

Karolinska Universitetssjukhuset Huddinge, Huddinge

14642

University of Rochester Medical Center, Rochester

18101

HaEmek Medical Center, Afula

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

20162

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

20814

National Institutes of Health, Bethesda

21029

"Municipal non-profit enterprise Vinnytsia city clinical hospital No. 1", Vinnytsia

21280

Dicle University, Medical Faculty, Diyarbakır

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia

28046

Hospital Universitario La Paz, Madrid

30625

Medizinische Hochschule Hannover, Hanover

33136

University of Miami Schiff Center for Liver Disease, Miami

33604

CHU Bordeaux - Hôpital Haut-Lévêque, Pessac

34362

The Lady Davis Carmel Medical Center, Haifa

35100

Ege University Medical Faculty, Izmir

36011

"Municipal Enterprise Poltava Regional Clinical Infectious Hospital of Poltava Regional Council", Poltava

38043

CHU de Grenoble - Hôpital Nord, La Tronche

40000

University Hospital of Sumy State University, Sumy

43100

Azienda Ospedaliero Universitaria di Parma, Parma

45147

Universitaetsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

48202

Henry Ford Health System, Detroit

50004

Changhua Christian Hospital, Changhua

52242

University of Iowa Hospitals & Clinics, Iowa City

52363

Chaim Sheba Medical Center, Ramat Gan

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

60590

Goethe Universität Frankfurt Am Main, Frankfurt am Main

60612

Rush University Medical Center, Chicago

61039

"Hospital of the state institution National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine", Kharkiv

67098

CHU Strasbourg - Hôpital Hautepierre, Strasbourg

69004

Centre Hospitalier de la Croix Rousse, Lyon

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

71100

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, Foggia

72076

Universitaetsklinikum Tuebingen, Tübingen

73071

Central Sooner Research, Norman

74800

The Aga Khan University, Karachi

77030

Baylor St. Luke's Medical Center, Houston

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

79182

Falu Lasarett, Falun

80131

"Azienda Ospedaliera Universitaria Federico II", Napoli

84001

Soroka University Medical Center, Beersheba

90036

Ruane Clinical Research Group Inc., Los Angeles

90057

Asia Pacific Liver Center, Los Angeles

91031

Shaare Zedek Medical Center, Jerusalem

92110

Hôpital Beaujon, Clichy

93140

Hôpital Jean Verdier, Bondy

93701

UCSF Fresno, Fresno

94303

Stanford University, Palo Alto

94804

Hôpital Paul Brousse, Villejuif

95817

University of California Davis Health System, Sacramento

95825

Kaiser Permanente Medical Center Sacramento, Sacramento

98124

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

121170

Modern Medicine Clinic, LLC, Moscow

127083

H-Clinic, LLC, Moscow

127473

National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation, Moscow

350000

Krasnodar specialized clinical infectious diseases hospital, Krasnodar

355017

"State Budgetary Educational Institution of Higher Profesional Education Stavropol State Medical University of MoH", Stavropol

357502

Clinica UZI 4D, LLC, Pyatigorsk

400006

Spitalul Clinic Judetean de Urgenta Cluj Napoca, Cluj-Napoca

443011

"Medical University Reaviz", Samara

443063

Hepatolog, LLC, Samara

454052

Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department., Chelyabinsk

630099

Healthy Family, LLC, Novosibirsk

677005

"Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) Yakut Republican clinical hospital", Yakutsk

2210001

Galilee Medical Center, Nahariya

3109601

Rambam Health Care Center, Haifa

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

06510-3206

Yale University Medical Center, New Haven

75390-8857

University of Texas Southwestern Medical Center, Dallas

T2N 4Z6

University of Calgary, Calgary

M5G 2C4

University Health Network, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

H4A 3J1

McGill University Health Centre/Glen Site / Royal Victoria Hospital, Montreal

06200

CHU Nice - Hôpital de l'Archet 2, Nice

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma

MD-2025

Rtl Sm Srl, Chisinau

14230-0054

The Liver Center, Ulaanbaatar

010719

S.C MedLife S.A, Bucharest

010825

"Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila", Bucharest

021105

"Institutul National de Boli Infectioase Prof. Dr. Matei Bals", Bucharest

022328

Institutul Clinic Fundeni, Bucharest

030303

"Fundatia Dr. Victor Babes", Bucharest

08035

Hospital Universitari Vall d'Hebron, Barcelona

205 02

Skånes Universitetssjukhus, Malmo

Unknown

Koc University Hospital, Istanbul

01135

"Medical Center Harmony of Beauty, LLC", Kyiv

02091

Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC, Kyiv

03035

"Medical Center Preventclinic, LLC", Kyiv

E1 1BB

Royal London Hospital, London

G12 0YN

Gartnavel General Hospital, Glasgow

Sponsors
All Listed Sponsors
lead

Eiger BioPharmaceuticals

INDUSTRY

NCT03719313 - Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a | Biotech Hunter | Biotech Hunter