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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Alisporivir

Peginterferon alfa-2a

Ribavirin

ALV Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Chronic hepatitis C, Cyclophilin inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Chronic HCV infection
HCV genotype 1
No previous treatment for hepatitis C infection
Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

Exclusion criteria:

HCV genotype different from genotype 1 or co-infection with other HCV genotype
Co-infection with Hepatitis B or HIV
Any other cause of relevant liver disease other than HCV
Presence or history of hepatic decompensation
Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm A

Treatment Arm B

Treatment Arm C

Treatment Arm D

Arm Description

Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment

Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)

Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks

ALV Placebo with PEG and RBV for 48 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)

SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.

Secondary Outcome Measures

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.

Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment

EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.

Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment

pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.

Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment

cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.

Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment

eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.

Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks

ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).

Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks

ALT abnormalities were summarized as participants who had either: ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline ALT > 3 x ULN during the study and > 2 x ULN at baseline

Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks

Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Full Information

NCT ID

NCT01318694

First Posted

March 17, 2011

Last Updated

August 5, 2016

Sponsor

Debiopharm International SA

1. Study Identification

Unique Protocol Identification Number

NCT01318694

Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Debiopharm International SA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

6. Conditions and Keywords

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

Hepatitis C

Keywords

Chronic hepatitis C, Cyclophilin inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1081 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm A

Arm Type

Experimental

Arm Description

Arm Title

Treatment Arm B

Arm Type

Experimental

Arm Description

Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)

Arm Title

Treatment Arm C

Arm Type

Experimental

Arm Description

Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks

Arm Title

Treatment Arm D

Arm Type

Active Comparator

Arm Description

ALV Placebo with PEG and RBV for 48 weeks

Intervention Type

Drug

Intervention Name(s)

Alisporivir

Other Intervention Name(s)

DEB025, ALV

Intervention Description

ALV 200 mg soft gel capsules administered orally

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa-2a

Other Intervention Name(s)

Pegasys®, PEG

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Other Intervention Name(s)

Copegus®, RBV

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ALV Placebo

Other Intervention Name(s)

Placebo

Intervention Description

ALV placebo soft gel capsules administered orally

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)

Description

SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.

Time Frame

12 weeks after the end of treatment

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

Description

SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

Time Frame

24 weeks after the end of treatment

Title

Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

Description

RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.

Time Frame

after 4 weeks of treatment

Title

Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment

Description

EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.

Time Frame

after 12 weeks of treatment

Title

Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment

Description

pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.

Time Frame

after 12 weeks of treatment

Title

Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment

Description

cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.

Time Frame

after 12 weeks of treatment

Title

Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment

Description

eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.

Time Frame

from 4 to 12 weeks of treatment

Title

Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks

Description

ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).

Time Frame

at treatment end within 48 weeks

Title

Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks

Description

Time Frame

within 48 weeks

Title

Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks

Description

Time Frame

within 48 weeks

Title

Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks

Description

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Time Frame

within 48 weeks

Title

Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks

Description

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Time Frame

within 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Chronic HCV infection HCV genotype 1 No previous treatment for hepatitis C infection Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months Exclusion criteria: HCV genotype different from genotype 1 or co-infection with other HCV genotype Co-infection with Hepatitis B or HIV Any other cause of relevant liver disease other than HCV Presence or history of hepatic decompensation Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92101

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

Facility Name

Novartis Investigative Site

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Novartis Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Novartis Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71130-3932

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Novartis Investigative Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Novartis Investigative Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11230

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Novartis Investigative Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246-2096

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Novartis Investigative Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Novartis Investigative Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23602

Country

United States

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1405BCK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5004BAL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Novartis Investigative Site

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Novartis Investigative Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4n1

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1J4

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

v6z 2k5

Country

Canada

Facility Name

Novartis Investigative Site

City

Downsview

State/Province

Ontario

ZIP/Postal Code

M3N 2Z9

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Novartis Investigative Site

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24146

Country

Germany

Facility Name

Novartis Investigative Site

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Hongkong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Bekescsaba

ZIP/Postal Code

H-5600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1126

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20121

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80135

Country

Italy

Facility Name

Novartis Investigative Site

City

Yangsan-si

State/Province

Gyeongsangnam-Do

ZIP/Postal Code

626-770

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Kyunggi

State/Province

Kyeonggi

ZIP/Postal Code

463-712

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Pusan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

México

State/Province

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85-030

Country

Poland

Facility Name

Novartis Investigative Site

City

Chorzów

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25-317

Country

Poland

Facility Name

Novartis Investigative Site

City

Lódz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

050524

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700111

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

ZIP/Postal Code

200515

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

ZIP/Postal Code

700506

Country

Romania

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

111123

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119333

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.- Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Novartis Investigative Site

City

Chia-Yi

ZIP/Postal Code

600

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Niaosong Township

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Yun-Lin

ZIP/Postal Code

640

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hanoi

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

Country

Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial