A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01464827
First received: September 28, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This is a study of combination direct-acting antiviral agents (DAA) and/or Ribavirin (RBV) in subjects with chronic Hepatitis C Virus (HCV).


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Drug: ABT-450/r
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Safety of all treatment regimens [ Time Frame: Baseline to End of Active Treatment (up to 24 weeks) ] [ Designated as safety issue: Yes ]
    Assess the safety of all treatment regimens

  • Percentage of subjects achieving 24-week sustained virologic response (SVR24) following treatment with different durations of 3 DAAs (direct acting anti-virals) and RBV (ribavirin) in HCV (HepatitisC) genotype 1-infected treatment-naïve adults [ Time Frame: Post Treatment Week 24 ] [ Designated as safety issue: No ]
    Assess the percentage of subjects achieving SVR24 (HCV RNA (Ribonucleic acid) < LLOQ (lower limit of quantitation) at post-treatment Week 24) following treatment with different durations of 3 DAAs (ABT-450/r, ABT-267, and ABT-333) and RBV in HCV genotype 1-infected treatment-naïve adults


Secondary Outcome Measures:
  • Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment of different durations with 3 DAAs with RBV in treatment naïve and null responder subjects [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    Compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment of different durations with 3 DAAs (ABT-450/r, ABT-267, and ABT-333) with RBV in treatment naïve and null responder subjects

  • Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV versus 3 DAAs without RBV in treatment naïve subjects [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    Compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/r, ABT-267, and ABT-333) with RBV versus 3 DAAs without RBV in treatment naïve subjects

  • Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs with RBV versus 3 DAAs with RBV in treatment naïve and null responder subjects [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    Compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/r and ABT-333) with RBV versus 3 DAAs (ABT-450/r, ABT-267, and ABT-333) with RBV in treatment naïve subjects and null responder subjects

  • Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV in with different doses of ABT-450/r in treatment treatment naïve and null responder subjects [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    Compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with different doses of ABT-450/r with RBV in treatment treatment naïve and null responder subjects

  • Any emerged or enriched mutations Post-Baseline by mixed population and/or clonal sequencing [ Time Frame: Day 1 to Post-Treatment Week 48 or Premature Discontinuation ] [ Designated as safety issue: No ]
    To examine any emerged or enriched mutations Post-Baseline by mixed population and/or clonal sequencing


Enrollment: 580
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
ABT-450/r, ABT-267, ABT-333, Ribavirin (RBV) in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group B
ABT-450/r and ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group C
ABT-450/r, ABT-267, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group D
ABT-450/r, ABT-267, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group E
ABT-450/r, ABT-267, ABT-333 in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Experimental: Group F
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group G
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group H
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group I
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group J
ABT-450/r, ABT-267, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group K
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group L
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group M
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: Group N
ABT-450/r, ABT-267, ABT-333, RBV in combination
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)

Detailed Description:

A study to evaluate the safety and effect of experimental drugs ABT-450, ABT-267, ABT-333, ritonavir, and Ribavirin in people with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 prior null-responders to previous treatment with pegylated interferon (pegIFN) and Ribavirin (RBV)
  • No evidence of liver cirrhosis

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464827

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 55530
Birmingham, Alabama, United States, 35215
Site Reference ID/Investigator# 57583
Birmingham, Alabama, United States, 35209
Site Reference ID/Investigator# 55385
Dothan, Alabama, United States, 36305
United States, Arizona
Site Reference ID/Investigator# 55500
Phoenix, Arizona, United States, 85054
Site Reference ID/Investigator# 55382
Tucson, Arizona, United States, 85724
United States, California
Site Reference ID/Investigator# 61042
Bakersfield, California, United States, 93301
Site Reference ID/Investigator# 43651
Coronado, California, United States, 92118
Site Reference ID/Investigator# 43652
Costa Mesa, California, United States, 92626
Site Reference ID/Investigator# 59130
Los Angeles, California, United States, 90048
Site Reference ID/Investigator# 43565
San Diego, California, United States, 92123
United States, Colorado
Site Reference ID/Investigator# 43910
Aurora, Colorado, United States, 80045
United States, Florida
Site Reference ID/Investigator# 43572
Bradenton, Florida, United States, 34209
Site Reference ID/Investigator# 43584
Fort Pierce, Florida, United States, 34982
Site Reference ID/Investigator# 43917
Gainesville, Florida, United States, 32610
Site Reference ID/Investigator# 55384
Jacksonville, Florida, United States, 32256
Site Reference ID/Investigator# 55531
Wellington, Florida, United States, 33414
Site Reference ID/Investigator# 44610
Wellington, Florida, United States, 33414
Site Reference ID/Investigator# 55536
Zephyrhills, Florida, United States, 33542
United States, Georgia
Site Reference ID/Investigator# 55540
Macon, Georgia, United States, 31201
Site Reference ID/Investigator# 55527
Marietta, Georgia, United States, 30060
United States, Illinois
Site Reference ID/Investigator# 44621
Chicago, Illinois, United States, 60637
United States, Indiana
Site Reference ID/Investigator# 43576
Indianapolis, Indiana, United States, 46202-5121
United States, Kentucky
Site Reference ID/Investigator# 55383
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Site Reference ID/Investigator# 59124
Shreveport, Louisiana, United States, 71103
United States, Maryland
Site Reference ID/Investigator# 43568
Annapolis, Maryland, United States, 21401
Site Reference ID/Investigator# 55901
Baltimore, Maryland, United States, 21201
Site Reference ID/Investigator# 43588
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Site Reference ID/Investigator# 55534
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 43656
Springfield, Massachusetts, United States, 01105
United States, Michigan
Site Reference ID/Investigator# 43655
Ann Arbor, Michigan, United States, 48109-0848
Site Reference ID/Investigator# 43913
Detroit, Michigan, United States, 48202
United States, Minnesota
Site Reference ID/Investigator# 43587
St. Paul, Minnesota, United States, 55114
United States, Mississippi
Site Reference ID/Investigator# 43661
Jackson, Mississippi, United States, 39202
United States, Missouri
Site Reference ID/Investigator# 43569
Kansas City, Missouri, United States, 64131
Site Reference ID/Investigator# 44608
St. Louis, Missouri, United States, 63104
United States, New Jersey
Site Reference ID/Investigator# 55526
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Site Reference ID/Investigator# 43566
Manhasset, New York, United States, 11030
Site Reference ID/Investigator# 59133
Monticello, New York, United States, 12701
Site Reference ID/Investigator# 43586
New York, New York, United States, 10016
Site Reference ID/Investigator# 43573
New York, New York, United States, 10021
Site Reference ID/Investigator# 55532
Poughkeepsie, New York, United States, 12601
Site Reference ID/Investigator# 55386
Rochester, New York, United States, 14625
United States, North Carolina
Site Reference ID/Investigator# 55538
Charlotte, North Carolina, United States, 28207
Site Reference ID/Investigator# 55522
Fayetteville, North Carolina, United States, 28304
Site Reference ID/Investigator# 55542
Statesville, North Carolina, United States, 28677
United States, Ohio
Site Reference ID/Investigator# 55533
Cincinnati, Ohio, United States, 45242
Site Reference ID/Investigator# 43665
Cincinnati, Ohio, United States, 45267-0595
United States, Oregon
Site Reference ID/Investigator# 43585
Medford, Oregon, United States, 97504
Site Reference ID/Investigator# 55539
Portland, Oregon, United States, 97225
United States, Pennsylvania
Site Reference ID/Investigator# 56622
Philadelphia, Pennsylvania, United States, 19106
United States, Tennessee
Site Reference ID/Investigator# 55723
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 43592
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 43659
Nashville, Tennessee, United States, 37203
United States, Texas
Site Reference ID/Investigator# 59132
Houston, Texas, United States, 77005
Site Reference ID/Investigator# 43577
San Antonio, Texas, United States, 78215
United States, Virginia
Site Reference ID/Investigator# 43662
Annandale, Virginia, United States, 22003
Site Reference ID/Investigator# 43666
Newport News, Virginia, United States, 23602
United States, Washington
Site Reference ID/Investigator# 43574
Seattle, Washington, United States, 98101
United States, Wisconsin
Site Reference ID/Investigator# 43578
Madison, Wisconsin, United States, 53792-5124
Site Reference ID/Investigator# 55387
Milwaukee, Wisconsin, United States, 53215
Australia
Site Reference ID/Investigator# 44850
Adelaide, Australia, 5000
Site Reference ID/Investigator# 44849
Herston, Australia, QLD 4029
Site Reference ID/Investigator# 44852
Kogarah, Australia, 2217
Canada
Site Reference ID/Investigator# 44084
Calgary, Canada, T2N 4Z6
Site Reference ID/Investigator# 43905
Vancouver, Canada, V5Z 1H2
France
Site Reference ID/Investigator# 44755
Clichy, France, 92110
Site Reference ID/Investigator# 44758
Creteil, France, 94010
Site Reference ID/Investigator# 58884
Lyon, France, 69004
Site Reference ID/Investigator# 58887
Marseilles, France, 13285
Site Reference ID/Investigator# 58886
Montpellier - Cedex 5, France, 34295
Site Reference ID/Investigator# 44754
Paris, France, 75679
Site Reference ID/Investigator# 58889
Pessac, France, 33600
Site Reference ID/Investigator# 44760
Vandoeuvre Les Nancy, France, 54511
Germany
Site Reference ID/Investigator# 59304
Berlin, Germany, 10969
Site Reference ID/Investigator# 59303
Berlin, Germany, 13353
Site Reference ID/Investigator# 46103
Frankfurt, Germany, 60590
Site Reference ID/Investigator# 46106
Hamburg, Germany, 20099
Site Reference ID/Investigator# 46102
Hannover, Germany, 30625
Site Reference ID/Investigator# 58922
Kiel, Germany, 24146
Site Reference ID/Investigator# 46105
Wuerzburg, Germany, 97080
New Zealand
Site Reference ID/Investigator# 44847
Auckland, New Zealand, 1142
Puerto Rico
Site Reference ID/Investigator# 43672
San Juan, Puerto Rico, 00927
Site Reference ID/Investigator# 43675
San Juan, Puerto Rico, 00936-5067
Spain
Site Reference ID/Investigator# 46485
Barcelona, Spain, 08003
Site Reference ID/Investigator# 45668
Barcelona, Spain, 08035
Site Reference ID/Investigator# 45363
Barcelona, Spain, 08028
Site Reference ID/Investigator# 46484
Madrid, Spain, 28034
Site Reference ID/Investigator# 45667
Madrid, Spain, 28046
Site Reference ID/Investigator# 45671
Majadahonda (Madrid), Spain, 28220
Site Reference ID/Investigator# 46583
Seville, Spain, 41014
Site Reference ID/Investigator# 45405
Valencia, Spain, 46014
United Kingdom
Site Reference ID/Investigator# 57545
Dundee, United Kingdom, DD1 9SY
Site Reference ID/Investigator# 57547
London, United Kingdom, NW3 2QG
Site Reference ID/Investigator# 59262
London, United Kingdom, E1 1BB
Site Reference ID/Investigator# 58811
London, United Kingdom, SE5 9RS
Site Reference ID/Investigator# 57882
Nottingham, United Kingdom, NG7 2UH
Site Reference ID/Investigator# 57543
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Daniel Cohen, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01464827     History of Changes
Other Study ID Numbers: M11-652, 2010-022455-31
Study First Received: September 28, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence francaise de securite sanitaire des produits de sante (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Chile: Ministry of Health
Mexico: Ministry of Health
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AbbVie:
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
HCV
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014