Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

PHASE3CompletedINTERVENTIONAL
Enrollment

880

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

September 30, 2014

Conditions
Hepatitis C Virus (HCV)
Interventions
BIOLOGICAL

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

BIOLOGICAL

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks

BIOLOGICAL

Pegylated interferon alfa-2a (pegIFNα-2a)

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

DRUG

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 24 weeks

DRUG

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 12 weeks

DRUG

Daclatasvir

Tablets, Oral, 60 mg, Once daily, 12 weeks

DRUG

Placebo matching Daclatasvir

Tablets, Oral, 0 mg, Once daily, 12 weeks

Trial Locations (124)

402

Local Institution, Taichung

704

Local Institution, Tainan City

833

Local Institution, Kaohsiung City

1070

Local Institution, Brussels

2000

Local Institution, Prov de Santa Fe

2010

Local Institution, Darlinghurst

2031

Local Institution, Randwick

2050

Local Institution, Camperdown

2139

Local Institution, Concord

2145

Local Institution, Westmead Nsw

3000

Local Institution, Leuven

3004

Local Institution, Melbourne

3050

Local Institution, Parville

3168

Local Institution, Clayton Vic

4000

Local Institution, Liège

4029

Local Institution, Herston

4102

Local Institution, Brisbane

4120

Local Institution, Greenslopes

5000

Local Institution, Córdoba

Local Institution, Adelaide

6160

Local Institution, Fremantle

7600

Local Institution, Mar del Plata

14000

Local Institution, Tlalpan

15213

University Of Pittsburgh Medical Center, Ctr For Liver Diseases, Pittsburgh

20122

Local Institution, Milan

20142

Local Institution, Milan

28100

Local Institution, Novara

28204

Carolinas Medical Center, Charlotte

30060

Gastrointestinal Specialists Of Georgia, Marietta

32803

Orlando Immunology Center, Orlando

32806

Orlando Infectious Disease Center, Orlando

34295

Local Institution, Montpellier

44500

Local Institution, Guadalajara

44650

Local Institution, Guadalajara

45249

Consultants For Clinical Research, Cincinnati

48202

Henry Ford Hospital, Detroit

50134

Local Institution, Florence

54006

Local Institution, Thessaloniki

64041

Local Institution, Yunlin

74135

Healthcare Research Consultants, Tulsa

76012

Texas Clinical Research Institute, Llc, Arlington

77030

St. Luke'S Episcopal Hospital - Baylor College Of Medicine, Houston

80131

Local Institution, Napoli

80756

Local Institution, Kaohsiung City

84123

Clinical Research Centers Of America, Murray

85054

Mayo Clinic Arizona, Phoenix

92024

Local Institution, Auckland

92114

Precision Research Institute, Llc, San Diego

92118

Local Institution, Clichy

92123

Medical Associates Research Group, San Diego

94010

Local Institution, Créteil

94110

University Of California, San Francisco/Sf General Hospital, San Francisco

94118

Kaiser Permanente Medical Center, San Francisco

96813

The Queen'S Liver Center, Honolulu

107996

Local Institution, Moscow

117593

Local Institution, Moscow

119228

Local Institution, Singapore

119992

Local Institution, Moscow

121170

Local Institution, Moscow

169608

Local Institution, Singapore

190103

Local Institution, Saint Petersburg

194044

Local Institution, Saint Petersburg

197376

Local Institution, Saint Petersburg

214018

Local Institution, Smolensk

443063

Local Institution, Samara

454052

Local Institution, Chelyabinsk

529889

Local Institution, Singapore

660049

Local Institution, Krasnoyarsk

664003

Local Institution, Irkutsk

1058470

Local Institution, Minato-ku

1138655

Local Institution, Bunkyo-ku

1808610

Local Institution, Musashino-shi

2138587

Local Institution, Kawasaki-shi

3380001

Local Institution, Saitama

3500495

Local Institution, Iruma-gun

6408158

Local Institution, Wakayama

6500047

Local Institution, Kobe

7008558

Local Institution, Okayama

7348551

Local Institution, Hiroshima

7608557

Local Institution, Takamatsu

8030816

Local Institution, Kitakyushu

8108563

Local Institution, Fukuoka

8158555

Local Institution, Fukuoka

8408571

Local Institution, Saga

8800003

Local Institution, Miyazaki

8908520

Local Institution, Kagoshima

06510

Yale University School Of Medicine, New Haven

C1119ACN

Local Institution, Autonoma

C1280AEB

Local Institution, Buenos Aires

C1121ABE

Local Institution, Ciudad de Buenos Aires

C1181ACH

Local Institution, Ciudad de Buenos Aires

B1878DVB

Local Institution, Quilmes

3065 VIC

Local Institution, Fitzroy

Unknown

Local Institution, Santiago

Local Institution, Hong Kong

Local Institution, Tai Po

Local Institution, Guadalajara

00029

Local Institution, Hus

06202

Local Institution, Nice

115 23

Local Institution, Athens

0600033

Local Institution, Sapporo

300-0053

Local Institution, Tsuchiura-shi

03720

Local Institution, Distrito Federal

06726

Local Institution, Mexico City

07760

Local Institution, Mexico City

06700

Local Institution, Mexico City

1105 AZ

Local Institution, Amsterdam

2333 ZA

Local Institution, Leiden

602-739

Local Institution, Busan

614-735

Local Institution, Busan

700-721

Local Institution, Daegu

705-703

Local Institution, Daegu

425-707

Local Institution, Gyeonggi-do

443-380

Local Institution, Gyeonggi-do

626-770

Local Institution, Gyeongsangnam-do

400-711

Local Institution, Incheon

403-720

Local Institution, Incheon

120-752

Local Institution, Seoul

135-710

Local Institution, Seoul

138-736

Local Institution, Seoul

HU3 2JZ

Local Institution, Hull

NG7 2UH

Local Institution, Nottingham

B15 2TH

Local Institution, Birmingham

E1 1BB

Local Institution, London

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY