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

September 28, 2011
March 25, 2014
October 2011
March 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01464827 on ClinicalTrials.gov Archive Site
  • 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
  • Percentage of subjects achieving SVR24 (HCV RNA < LLOD 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: Yes ]
    Compare the percentage of subjects achieving SVR24 (HCV RNA < LLOD 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 < LLOD 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 < LLOD 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 < LLOD 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 < LLOD 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 < LLOD 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 < LLOD 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
Not Provided
Not Provided
 
A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects
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) and/or Ribavirin (RBV) in subjects with chronic Hepatitis C Virus (HCV).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis C
  • Hepatitis C (HCV)
  • Hepatitis C Genotype 1
  • 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 A
    ABT-450/r, ABT-267, ABT-333, Ribavirin (RBV) in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group B
    ABT-450/r and ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: Group C
    ABT-450/r, ABT-267, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group D
    ABT-450/r, ABT-267, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group E
    ABT-450/r, ABT-267, ABT-333 in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
  • Experimental: Group F
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group G
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group H
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group I
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group J
    ABT-450/r, ABT-267, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group K
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group L
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group M
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-333
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
  • Experimental: Group N
    ABT-450/r, ABT-267, ABT-333, RBV in combination
    Interventions:
    • Drug: ABT-450/r
    • Drug: ABT-267
    • Drug: Ribavirin (RBV)
Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
580
September 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico,   Canada,   France,   New Zealand,   Australia,   Spain,   Germany,   United Kingdom
 
NCT01464827
M11-652, 2010-022455-31
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Daniel Cohen, MD AbbVie
AbbVie
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP