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ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Primary Purpose

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ABT-450

ABT-333

ABT-267

Ribavirin

Ritonavir

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, HCV, Chronic Hepatitis C

Eligibility Criteria

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

Inclusion Criteria:

Males and females 18-70 years old, inclusive
Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
Chronic hepatitis C virus (HCV), genotype 1 infection
Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
No evidence of liver cirrhosis

Exclusion Criteria:

Significant liver disease with any cause other than HCV as the primary cause
Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
Positive screen for drugs and alcohol
Significant sensitivity to any drug
Use of contraindicated or prohibited medications within 1 month of dosing
Abnormal laboratory tests

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Group G

Group H

Group I

Group J

Group K

Group L

Group M

Group N

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin

The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G).

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).

Full Information

NCT ID

NCT01464827

First Posted

September 28, 2011

Last Updated

April 2, 2015

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01464827

Brief Title

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Official Title

A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

Detailed Description

A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

6. Conditions and Keywords

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

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1

Keywords

Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, HCV, Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

580 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.

Arm Title

Group B

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Arm Title

Group C

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Arm Title

Group D

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Arm Title

Group E

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.

Arm Title

Group F

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Arm Title

Group G

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Arm Title

Group H

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Arm Title

Group I

Arm Type

Experimental

Arm Description

Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Arm Title

Group J

Arm Type

Experimental

Arm Description

Arm Title

Group K

Arm Type

Experimental

Arm Description

Arm Title

Group L

Arm Type

Experimental

Arm Description

Arm Title

Group M

Arm Type

Experimental

Arm Description

Arm Title

Group N

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ABT-450

Intervention Description

ABT-450 tablets

Intervention Type

Drug

Intervention Name(s)

ABT-333

Other Intervention Name(s)

Dasabuvir

Intervention Description

ABT-333 tablets

Intervention Type

Drug

Intervention Name(s)

ABT-267

Other Intervention Name(s)

Ombitasvir

Intervention Description

ABT-267 tablets

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Description

Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Other Intervention Name(s)

Norvir

Intervention Description

Ritonavir capsules

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin

Description

Time Frame

Post Treatment Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin

Description

Time Frame

Post-Treatment Week 24

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin

Description

Time Frame

Post-Treatment Week 24

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin

Description

Time Frame

Post-Treatment Week 24

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders

Description

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).

Time Frame

Post-Treatment Week 24

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: Males and females 18-70 years old, inclusive Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control Chronic hepatitis C virus (HCV), genotype 1 infection Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12) No evidence of liver cirrhosis Exclusion Criteria: Significant liver disease with any cause other than HCV as the primary cause Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody Positive screen for drugs and alcohol Significant sensitivity to any drug Use of contraindicated or prohibited medications within 1 month of dosing Abnormal laboratory tests

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Cohen, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 57583

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Site Reference ID/Investigator# 55530

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35215

Country

United States

Facility Name

Site Reference ID/Investigator# 55385

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Site Reference ID/Investigator# 55500

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Site Reference ID/Investigator# 55382

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Site Reference ID/Investigator# 61042

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Site Reference ID/Investigator# 43651

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Site Reference ID/Investigator# 43652

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Site Reference ID/Investigator# 59130

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Site Reference ID/Investigator# 43565

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Site Reference ID/Investigator# 43910

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Site Reference ID/Investigator# 43572

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Site Reference ID/Investigator# 43584

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

Site Reference ID/Investigator# 43917

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Site Reference ID/Investigator# 55384

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Site Reference ID/Investigator# 44610

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Site Reference ID/Investigator# 55531

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Site Reference ID/Investigator# 55536

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Site Reference ID/Investigator# 55540

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Site Reference ID/Investigator# 55527

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Site Reference ID/Investigator# 44621

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Site Reference ID/Investigator# 43576

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5121

Country

United States

Facility Name

Site Reference ID/Investigator# 55383

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Site Reference ID/Investigator# 59124

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Site Reference ID/Investigator# 43568

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Site Reference ID/Investigator# 55901

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Site Reference ID/Investigator# 43588

City

Lutherville

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Site Reference ID/Investigator# 55534

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Site Reference ID/Investigator# 43656

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01105

Country

United States

Facility Name

Site Reference ID/Investigator# 43655

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0848

Country

United States

Facility Name

Site Reference ID/Investigator# 43913

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Site Reference ID/Investigator# 43587

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

Facility Name

Site Reference ID/Investigator# 43661

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Site Reference ID/Investigator# 43569

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64131

Country

United States

Facility Name

Site Reference ID/Investigator# 44608

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Site Reference ID/Investigator# 55526

City

Egg Harbor Township

State/Province

New Jersey

ZIP/Postal Code

08234

Country

United States

Facility Name

Site Reference ID/Investigator# 43566

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Site Reference ID/Investigator# 59133

City

Monticello

State/Province

New York

ZIP/Postal Code

12701

Country

United States

Facility Name

Site Reference ID/Investigator# 43586

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Site Reference ID/Investigator# 43573

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Site Reference ID/Investigator# 55532

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Site Reference ID/Investigator# 55386

City

Rochester

State/Province

New York

ZIP/Postal Code

14625

Country

United States

Facility Name

Site Reference ID/Investigator# 55538

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Site Reference ID/Investigator# 55522

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Site Reference ID/Investigator# 55542

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677

Country

United States

Facility Name

Site Reference ID/Investigator# 55533

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Site Reference ID/Investigator# 43665

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0595

Country

United States

Facility Name

Site Reference ID/Investigator# 43585

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Site Reference ID/Investigator# 55539

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Site Reference ID/Investigator# 56622

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Site Reference ID/Investigator# 43592

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Site Reference ID/Investigator# 55723

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Site Reference ID/Investigator# 43659

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Site Reference ID/Investigator# 59132

City

Houston

State/Province

Texas

ZIP/Postal Code

77005

Country

United States

Facility Name

Site Reference ID/Investigator# 43577

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Site Reference ID/Investigator# 43662

City

Annandale

State/Province

Virginia

ZIP/Postal Code

22003

Country

United States

Facility Name

Site Reference ID/Investigator# 43666

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23602

Country

United States

Facility Name

Site Reference ID/Investigator# 43574

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Site Reference ID/Investigator# 43578

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-5124

Country

United States

Facility Name

Site Reference ID/Investigator# 55387

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Site Reference ID/Investigator# 44850

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

Site Reference ID/Investigator# 44849

City

Herston

ZIP/Postal Code

QLD 4029

Country

Australia

Facility Name

Site Reference ID/Investigator# 44852

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Site Reference ID/Investigator# 44084

City

Calgary

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Site Reference ID/Investigator# 43905

City

Vancouver

ZIP/Postal Code

V5Z 1H2

Country

Canada

Facility Name

Site Reference ID/Investigator# 44755

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

Site Reference ID/Investigator# 44758

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Site Reference ID/Investigator# 58884

City

Lyon

ZIP/Postal Code

69004

Country

France

Facility Name

Site Reference ID/Investigator# 58887

City

Marseilles

ZIP/Postal Code

13285

Country

France

Facility Name

Site Reference ID/Investigator# 58886

City

Montpellier - Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Site Reference ID/Investigator# 44754

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

Site Reference ID/Investigator# 58889

City

Pessac

ZIP/Postal Code

33600

Country

France

Facility Name

Site Reference ID/Investigator# 44760

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Site Reference ID/Investigator# 59304

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Site Reference ID/Investigator# 59303

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Site Reference ID/Investigator# 46103

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Site Reference ID/Investigator# 46106

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Site Reference ID/Investigator# 46102

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Site Reference ID/Investigator# 58922

City

Kiel

ZIP/Postal Code

24146

Country

Germany

Facility Name

Site Reference ID/Investigator# 46105

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Site Reference ID/Investigator# 44847

City

Auckland

ZIP/Postal Code

1142

Country

New Zealand

Facility Name

Site Reference ID/Investigator# 43672

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 43675

City

San Juan

ZIP/Postal Code

00936-5067

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 46485

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Site Reference ID/Investigator# 45363

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Site Reference ID/Investigator# 45668

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Site Reference ID/Investigator# 46484

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Site Reference ID/Investigator# 45667

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Site Reference ID/Investigator# 45671

City

Majadahonda (Madrid)

ZIP/Postal Code

28220

Country

Spain

Facility Name

Site Reference ID/Investigator# 46583

City

Seville

ZIP/Postal Code

41014

Country

Spain

Facility Name

Site Reference ID/Investigator# 45405

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Site Reference ID/Investigator# 57545

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 59262

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 57547

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 58811

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 57882

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 57543

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26100711

Citation

Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.

Results Reference

derived

PubMed Identifier

24428468

Citation

Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.

Results Reference

derived

Links:

URL

http://rxabbvie.com

Description

Related Info

Learn more about this trial

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

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ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

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