Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

PHASE2CompletedINTERVENTIONAL
Enrollment

459

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

May 31, 2013

Study Completion Date

May 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

Placebo

ALV placebo soft gel capsules administered orally

Trial Locations (75)

112

Novartis Investigative Site, Taipei

640

Novartis Investigative Site, Douliu

807

Novartis Investigative Site, Kaohsiung City

1070

Novartis Investigative Site, Brussels

1083

Novartis Investigative Site, Budapest

1126

Novartis Investigative Site, Budapest

2145

Novartis Investigative Site, Westmead

2217

Novartis Investigative Site, Kogarah

2747

Novartis Investigative Site, Kingswood

3000

Novartis Investigative Site, Leuven

3065

Novartis Investigative Site, Fitzroy

3168

Novartis Investigative Site, Clayton

4032

Novartis Investigative Site, Debrecen

7400

Novartis Investigative Site, Kaposvár

8000

Novartis Investigative Site, Székesfehérvár

10002

Novartis Investigative Site, Taipei

10021

Novartis Investigative Site, New York

10969

Novartis Investigative Site, Berlin

11230

Novartis Investigative Site, Brooklyn

20099

Novartis Investigative Site, Hamburg

20401

Novartis Investigative Site, Keelung

28029

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Majadahonda

32804

Novartis Investigative Site, Orlando

33305

Novartis Investigative Site, Lin-Ko

33607

Novartis Investigative Site, Tampa

34098

Novartis Investigative Site, Fatih / Istanbul

34209

Novartis Investigative Site, Bradenton

35040

Novartis Investigative Site, Izmir

35128

Novartis Investigative Site, Padua

40138

Novartis Investigative Site, Bologna

41014

Novartis Investigative Site, Seville

43100

Novartis Investigative Site, Parma

50012

Novartis Investigative Site, Antella - Bagno A Ripoli

50937

Novartis Investigative Site, Cologne

60590

Novartis Investigative Site, Frankfurt

62703

Novartis Investigative Site, Springfield

66606

Novartis Investigative Site, Topeka

75006

Novartis Investigative Site, Paris

76012

Novartis Investigative Site, Arlington

77030

Novartis Investigative Site, Houston

78215

Novartis Investigative Site, San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

83301

Novartis Investigative Site, Niaosong Township

90127

Novartis Investigative Site, Palermo

92101

Novartis Investigative Site, San Diego

92115

Novartis Investigative Site, San Diego

93003

Novartis Investigative Site, Ventura

96814

Novartis Investigative Site, Honolulu

96817

Novartis Investigative Site, Honolulu

700506

Novartis Investigative Site, Iași

01107

Novartis Investigative Site, Springfield

08234

Novartis Investigative Site, Egg Harbor Twp

75246-2096

Novartis Investigative Site, Dallas

06202

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

H-5600

Novartis Investigative Site, Békéscsaba

00161

Novartis Investigative Site, Roma

15-540

Novartis Investigative Site, Bialystok

91-347

Novartis Investigative Site, Lódz

01-201

Novartis Investigative Site, Warsaw

00909

Novartis Investigative Site, San Juan

050526

Novartis Investigative Site, Bucharest

030317

Novartis Investigative Site, Bucharest

021105

Novartis Investigative Site, Bucharest

020125

Novartis Investigative Site, Bucharest

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

06100

Novartis Investigative Site, Ankara

06800

Novartis Investigative Site, Ankara

E1 1BB

Novartis Investigative Site, London

NW3 2PR

Novartis Investigative Site, London

W2 1NY

Novartis Investigative Site, London

NG7 2UH

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY