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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01464827
First received: September 28, 2011
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  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, Multi-center 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) in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

U.S. FDA Resources

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


Estimated Enrollment: 560
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated 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-333
ABT-333 (tablets)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464827

  Show 96 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Daniel Cohen, MD AbbVie
  More Information

No publications provided

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 22, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (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
Chronic Hepatitis C
Hepatitis C Genotype 1
HCV
Interferon-Free

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

ClinicalTrials.gov processed this record on May 16, 2013