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

April 2, 2015 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

580

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Site Reference ID/Investigator# 44850
      • Herston, Australia, QLD 4029
        • Site Reference ID/Investigator# 44849
      • Kogarah, Australia, 2217
        • Site Reference ID/Investigator# 44852
  • Canada
      • Calgary, Canada, T2N 4Z6
        • Site Reference ID/Investigator# 44084
      • Vancouver, Canada, V5Z 1H2
        • Site Reference ID/Investigator# 43905
  • France
      • Clichy, France, 92110
        • Site Reference ID/Investigator# 44755
      • Creteil, France, 94010
        • Site Reference ID/Investigator# 44758
      • Lyon, France, 69004
        • Site Reference ID/Investigator# 58884
      • Marseilles, France, 13285
        • Site Reference ID/Investigator# 58887
      • Montpellier - Cedex 5, France, 34295
        • Site Reference ID/Investigator# 58886
      • Paris, France, 75679
        • Site Reference ID/Investigator# 44754
      • Pessac, France, 33600
        • Site Reference ID/Investigator# 58889
      • Vandoeuvre Les Nancy, France, 54511
        • Site Reference ID/Investigator# 44760
  • Germany
      • Berlin, Germany, 10969
        • Site Reference ID/Investigator# 59304
      • Berlin, Germany, 13353
        • Site Reference ID/Investigator# 59303
      • Frankfurt, Germany, 60590
        • Site Reference ID/Investigator# 46103
      • Hamburg, Germany, 20099
        • Site Reference ID/Investigator# 46106
      • Hannover, Germany, 30625
        • Site Reference ID/Investigator# 46102
      • Kiel, Germany, 24146
        • Site Reference ID/Investigator# 58922
      • Wuerzburg, Germany, 97080
        • Site Reference ID/Investigator# 46105
  • New Zealand
      • Auckland, New Zealand, 1142
        • Site Reference ID/Investigator# 44847
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Site Reference ID/Investigator# 43672
      • San Juan, Puerto Rico, 00936-5067
        • Site Reference ID/Investigator# 43675
  • Spain
      • Barcelona, Spain, 08003
        • Site Reference ID/Investigator# 46485
      • Barcelona, Spain, 08028
        • Site Reference ID/Investigator# 45363
      • Barcelona, Spain, 08035
        • Site Reference ID/Investigator# 45668
      • Madrid, Spain, 28034
        • Site Reference ID/Investigator# 46484
      • Madrid, Spain, 28046
        • Site Reference ID/Investigator# 45667
      • Majadahonda (Madrid), Spain, 28220
        • Site Reference ID/Investigator# 45671
      • Seville, Spain, 41014
        • Site Reference ID/Investigator# 46583
      • Valencia, Spain, 46014
        • Site Reference ID/Investigator# 45405
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Site Reference ID/Investigator# 57545
      • London, United Kingdom, E1 1BB
        • Site Reference ID/Investigator# 59262
      • London, United Kingdom, NW3 2QG
        • Site Reference ID/Investigator# 57547
      • London, United Kingdom, SE5 9RS
        • Site Reference ID/Investigator# 58811
      • Nottingham, United Kingdom, NG7 2UH
        • Site Reference ID/Investigator# 57882
      • Southampton, United Kingdom, SO16 6YD
        • Site Reference ID/Investigator# 57543
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Site Reference ID/Investigator# 57583
      • Birmingham, Alabama, United States, 35215
        • Site Reference ID/Investigator# 55530
      • Dothan, Alabama, United States, 36305
        • Site Reference ID/Investigator# 55385
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Site Reference ID/Investigator# 55500
      • Tucson, Arizona, United States, 85724
        • Site Reference ID/Investigator# 55382
    • California
      • Bakersfield, California, United States, 93301
        • Site Reference ID/Investigator# 61042
      • Coronado, California, United States, 92118
        • Site Reference ID/Investigator# 43651
      • Costa Mesa, California, United States, 92626
        • Site Reference ID/Investigator# 43652
      • Los Angeles, California, United States, 90048
        • Site Reference ID/Investigator# 59130
      • San Diego, California, United States, 92123
        • Site Reference ID/Investigator# 43565
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site Reference ID/Investigator# 43910
    • Florida
      • Bradenton, Florida, United States, 34209
        • Site Reference ID/Investigator# 43572
      • Fort Pierce, Florida, United States, 34982
        • Site Reference ID/Investigator# 43584
      • Gainesville, Florida, United States, 32610
        • Site Reference ID/Investigator# 43917
      • Jacksonville, Florida, United States, 32256
        • Site Reference ID/Investigator# 55384
      • Wellington, Florida, United States, 33414
        • Site Reference ID/Investigator# 44610
      • Wellington, Florida, United States, 33414
        • Site Reference ID/Investigator# 55531
      • Zephyrhills, Florida, United States, 33542
        • Site Reference ID/Investigator# 55536
    • Georgia
      • Macon, Georgia, United States, 31201
        • Site Reference ID/Investigator# 55540
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 55527
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator# 44621
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5121
        • Site Reference ID/Investigator# 43576
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Site Reference ID/Investigator# 55383
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Site Reference ID/Investigator# 59124
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Site Reference ID/Investigator# 43568
      • Baltimore, Maryland, United States, 21201
        • Site Reference ID/Investigator# 55901
      • Lutherville, Maryland, United States, 21093
        • Site Reference ID/Investigator# 43588
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Site Reference ID/Investigator# 55534
      • Springfield, Massachusetts, United States, 01105
        • Site Reference ID/Investigator# 43656
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0848
        • Site Reference ID/Investigator# 43655
      • Detroit, Michigan, United States, 48202
        • Site Reference ID/Investigator# 43913
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Site Reference ID/Investigator# 43587
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site Reference ID/Investigator# 43661
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Site Reference ID/Investigator# 43569
      • St. Louis, Missouri, United States, 63104
        • Site Reference ID/Investigator# 44608
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Site Reference ID/Investigator# 55526
    • New York
      • Manhasset, New York, United States, 11030
        • Site Reference ID/Investigator# 43566
      • Monticello, New York, United States, 12701
        • Site Reference ID/Investigator# 59133
      • New York, New York, United States, 10016
        • Site Reference ID/Investigator# 43586
      • New York, New York, United States, 10021
        • Site Reference ID/Investigator# 43573
      • Poughkeepsie, New York, United States, 12601
        • Site Reference ID/Investigator# 55532
      • Rochester, New York, United States, 14625
        • Site Reference ID/Investigator# 55386
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Site Reference ID/Investigator# 55538
      • Fayetteville, North Carolina, United States, 28304
        • Site Reference ID/Investigator# 55522
      • Statesville, North Carolina, United States, 28677
        • Site Reference ID/Investigator# 55542
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Site Reference ID/Investigator# 55533
      • Cincinnati, Ohio, United States, 45267-0595
        • Site Reference ID/Investigator# 43665
    • Oregon
      • Medford, Oregon, United States, 97504
        • Site Reference ID/Investigator# 43585
      • Portland, Oregon, United States, 97225
        • Site Reference ID/Investigator# 55539
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Site Reference ID/Investigator# 56622
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Site Reference ID/Investigator# 43592
      • Germantown, Tennessee, United States, 38138
        • Site Reference ID/Investigator# 55723
      • Nashville, Tennessee, United States, 37203
        • Site Reference ID/Investigator# 43659
    • Texas
      • Houston, Texas, United States, 77005
        • Site Reference ID/Investigator# 59132
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 43577
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Site Reference ID/Investigator# 43662
      • Newport News, Virginia, United States, 23602
        • Site Reference ID/Investigator# 43666
    • Washington
      • Seattle, Washington, United States, 98101
        • Site Reference ID/Investigator# 43574
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5124
        • Site Reference ID/Investigator# 43578
      • Milwaukee, Wisconsin, United States, 53215
        • Site Reference ID/Investigator# 55387

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group B
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group C
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group D
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group E
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group F
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group G
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group H
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group I
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group J
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group K
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group L
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.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group M
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 24 weeks.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir
Experimental: Group N
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 24 weeks.
Drug: ABT-450
ABT-450 tablets
Drug: ABT-333
ABT-333 tablets
Other Names:
  • Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Names:
  • Ombitasvir
Drug: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Drug: Ritonavir
Ritonavir capsules
Other Names:
  • Norvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).

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.
From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
Time Frame: Post Treatment Week 24

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).
Post Treatment Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Post-Treatment Week 24
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).
Post-Treatment Week 24
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
Time Frame: Post-Treatment Week 24
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).
Post-Treatment Week 24
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
Time Frame: Post-Treatment Week 24
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 with or without ribavirin (Group E versus Groups F + G + K + L).
Post-Treatment Week 24
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
Time Frame: Post-Treatment Week 24
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).
Post-Treatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Daniel Cohen, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-652
  • 2010-022455-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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