Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,081

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Hepatitis C
Interventions
DRUG

Alisporivir

ALV 200 mg soft gel capsules administered orally

DRUG

Peginterferon alfa-2a

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

DRUG

Ribavirin

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

DRUG

ALV Placebo

ALV placebo soft gel capsules administered orally

Trial Locations (146)

600

Novartis Investigative Site, Chiayi City

640

Novartis Investigative Site, Douliu

807

Novartis Investigative Site, Kaohsiung City

1070

Novartis Investigative Site, Brussels

1083

Novartis Investigative Site, Budapest

1090

Novartis Investigative Site, Brussels

1097

Novartis Investigative Site, Budapest

1126

Novartis Investigative Site, Budapest

2010

Novartis Investigative Site, Darlinghurst

2145

Novartis Investigative Site, Westmead

2217

Novartis Investigative Site, Kogarah

2747

Novartis Investigative Site, Kingswood

3065

Novartis Investigative Site, Fitzroy

4032

Novartis Investigative Site, Debrecen

4120

Novartis Investigative Site, Greenslopes

7400

Novartis Investigative Site, Kaposvár

7624

Novartis Investigative Site, Pécs

8000

Novartis Investigative Site, Székesfehérvár

9000

Novartis Investigative Site, Ghent

10002

Novartis Investigative Site, Taipei

10016

Novartis Investigative Site, New York

10021

Novartis Investigative Site, New York

10126

Novartis Investigative Site, Torino

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10969

Novartis Investigative Site, Berlin

11230

Novartis Investigative Site, Brooklyn

13353

Novartis Investigative Site, Berlin

14000

Novartis Investigative Site, Mexico City

16132

Novartis Investigative Site, Genova

20089

Novartis Investigative Site, Rozzano

20099

Novartis Investigative Site, Hamburg

20121

Novartis Investigative Site, Milan

20122

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

21202

Novartis Investigative Site, Baltimore

21229

Novartis Investigative Site, Baltimore

22031

Novartis Investigative Site, Fairfax

22332

Novartis Investigative Site, Incheon

23602

Novartis Investigative Site, Newport News

24146

Novartis Investigative Site, Kiel

27100

Novartis Investigative Site, Pavia

28029

Novartis Investigative Site, Madrid

28203

Novartis Investigative Site, Charlotte

28222

Novartis Investigative Site, Majadahonda

28304

Novartis Investigative Site, Fayetteville

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

32751

Novartis Investigative Site, Maitland

33607

Novartis Investigative Site, Tampa

34209

Novartis Investigative Site, Bradenton

35128

Novartis Investigative Site, Padua

38043

Novartis Investigative Site, Grenoble

40002

Novartis Investigative Site, Khon Kaen

40138

Novartis Investigative Site, Bologna

Novartis Investigative Site, Bologna

40447

Novartis Investigative Site, Taichung

41014

Novartis Investigative Site, Seville

45147

Novartis Investigative Site, Essen

46014

Novartis Investigative Site, Valencia

46237

Novartis Investigative Site, Indianapolis

50200

Novartis Investigative Site, Chiang Mai

50937

Novartis Investigative Site, Cologne

55131

Novartis Investigative Site, Mainz

55404

Novartis Investigative Site, Minneapolis

60590

Novartis Investigative Site, Frankfurt

62703

Novartis Investigative Site, Springfield

63110

Novartis Investigative Site, St Louis

63128

Novartis Investigative Site, St Louis

64020

Novartis Investigative Site, Monterrey

68198

Novartis Investigative Site, Omaha

69317

Novartis Investigative Site, Lyon

75390

Novartis Investigative Site, Dallas

76012

Novartis Investigative Site, Arlington

77030

Novartis Investigative Site, Houston

78215

Novartis Investigative Site, San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

80135

Novartis Investigative Site, Napoli

83301

Novartis Investigative Site, Niaosong Township

84124

Novartis Investigative Site, Salt Lake City

90110

Novartis Investigative Site, Songkhla

90127

Novartis Investigative Site, Palermo

90211

Novartis Investigative Site, Beverly Hills

92101

Novartis Investigative Site, San Diego

92110

Novartis Investigative Site, Clichy

92123

Novartis Investigative Site, San Diego

92128

Novartis Investigative Site, San Diego

93003

Novartis Investigative Site, Ventura

94612

Novartis Investigative Site, Oakland

94805

Novartis Investigative Site, Villejuif

111123

Novartis Investigative Site, Moscow

119333

Novartis Investigative Site, Moscow

119992

Novartis Investigative Site, Moscow

127473

Novartis Investigative Site, Moscow

194044

Novartis Investigative Site, Saint Petersburg

197376

Novartis Investigative Site, Saint Petersburg

200515

Novartis Investigative Site, Craiova

400006

Novartis Investigative Site, Cluj-Napoca

700111

Novartis Investigative Site, Iași

700506

Novartis Investigative Site, Iași

71130-3932

Novartis Investigative Site, Shreveport

07102

Novartis Investigative Site, Newark

75246-2096

Novartis Investigative Site, Dallas

C1125ABE

Novartis Investigative Site, Buenos Aires

C1405BCK

Novartis Investigative Site, Buenos Aires

X5004BAL

Novartis Investigative Site, Córdoba

S2000DSV

Novartis Investigative Site, Rosario

S2002KDS

Novartis Investigative Site, Rosario

T2N 4n1

Novartis Investigative Site, Calgary

V5Z 1J4

Novartis Investigative Site, Vancouver

V5Z 1M9

Novartis Investigative Site, Vancouver

v6z 2k5

Novartis Investigative Site, Vancouver

M3N 2Z9

Novartis Investigative Site, Downsview

N6A 4G5

Novartis Investigative Site, London

M5G 2C4

Novartis Investigative Site, Toronto

M5T 2S8

Novartis Investigative Site, Toronto

04103

Novartis Investigative Site, Leipzig

Unknown

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Hanoi

Novartis Investigative Site, Ho Chi Minh City

H-5600

Novartis Investigative Site, Békéscsaba

00133

Novartis Investigative Site, Roma

15-540

Novartis Investigative Site, Bialystok

85-030

Novartis Investigative Site, Bydgoszcz

41-500

Novartis Investigative Site, Chorzów

25-317

Novartis Investigative Site, Kielce

91-347

Novartis Investigative Site, Lódz

00909

Novartis Investigative Site, San Juan

050524

Novartis Investigative Site, Bucharest

030317

Novartis Investigative Site, Bucharest

020125

Novartis Investigative Site, Bucharest

602-739

Novartis Investigative Site, Busan

626-770

Novartis Investigative Site, Yangsan

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

463-712

Novartis Investigative Site, Kyunggi

602-715

Novartis Investigative Site, Busan

614-735

Novartis Investigative Site, Pusan

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

B15 2TT

Novartis Investigative Site, Birmingham

E1 1BB

Novartis Investigative Site, London

SE5 9RS

Novartis Investigative Site, London

W2 1NY

Novartis Investigative Site, London

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

NG7 2UH

Novartis Investigative Site, Nottingham

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