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

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: April 2, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
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:
  • 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). ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Post Treatment Week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
    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).


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
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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: Ombitasvir
Drug: Ritonavir
Ritonavir capsules
Other Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: 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 Name: Dasabuvir
Drug: ABT-267
ABT-267 tablets
Other Name: 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 Name: Norvir

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.

  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 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
  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# 44610
Wellington, Florida, United States, 33414
Site Reference ID/Investigator# 55531
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, 71105
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# 43573
New York, New York, United States, 10021
Site Reference ID/Investigator# 43586
New York, New York, United States, 10016
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# 43665
Cincinnati, Ohio, United States, 45267-0595
Site Reference ID/Investigator# 55533
Cincinnati, Ohio, United States, 45242
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# 43592
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 55723
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# 45667
Madrid, Spain, 28046
Site Reference ID/Investigator# 46484
Madrid, Spain, 28034
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# 58811
London, United Kingdom, SE5 9RS
Site Reference ID/Investigator# 59262
London, United Kingdom, E1 1BB
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

Additional 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
Results First Received: December 23, 2014
Last Updated: April 2, 2015
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 July 26, 2015