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

  Show 97 Study Locations
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 C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 26, 2014