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A Study to Evaluate Chronic Hepatitis C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01716585
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : January 6, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE October 18, 2012
First Posted Date  ICMJE October 30, 2012
Results First Submitted Date  ICMJE December 23, 2014
Results First Posted Date  ICMJE January 6, 2015
Last Update Posted Date November 9, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ]
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
Percentage of subjects with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ]
Hepatitis C virus ribonucleic acid less than the lower limit of quantification
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period [ Time Frame: At 12 weeks ]
    Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
  • Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
  • Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
  • Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [ Time Frame: 12 weeks after the last actual dose of active study drug ]
    Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
  • Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [ Time Frame: Within 12 weeks post-treatment ]
    Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
  • Percentage of subjects with rapid virologic response [ Time Frame: At 4 weeks ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification at week 4
  • Percentage of subjects with end of treatment response [ Time Frame: At 12 weeks ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification at the end of treatment
  • Percentage of subjects with alanine aminotransferase normalization [ Time Frame: At 12 weeks ]
    Alanine aminotransferase less than or equal to the upper limit of normal at final treatment visit for subjects with alanine aminotransferase greater than the upper limit of normal at baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Chronic Hepatitis C Infection
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Infection
Intervention  ICMJE
  • Drug: ABT-450/r/ABT-267, ABT-333
    ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
    • ABT-267 also known as ombitasvir
    • ABT-450 also known as paritaprevir
    • ABT-333 also known as dasabuvir
    • Viekira PAK
  • Drug: Ribavirin
    Capsule (double-blind treatment period), tablet (open-label treatment period)
  • Drug: Placebo for ABT-450/r/ABT-267
    Tablet
  • Drug: Placebo for ABT-333
    Tablet
  • Drug: Placebo for ribavirin
    Capsule
Study Arms  ICMJE
  • Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV
    Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Interventions:
    • Drug: ABT-450/r/ABT-267, ABT-333
    • Drug: Ribavirin
  • Experimental: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
    Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Interventions:
    • Drug: ABT-450/r/ABT-267, ABT-333
    • Drug: Ribavirin
    • Drug: Placebo for ABT-450/r/ABT-267
    • Drug: Placebo for ABT-333
    • Drug: Placebo for ribavirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
636
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2012)
600
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
  • Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
  • Subject has never received antiviral treatment for hepatitis C infection
  • No evidence of liver cirrhosis

Exclusion Criteria:

  • Positive screen for drugs or alcohol
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Certain predefined abnormal laboratory tests
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Canada,   France,   Germany,   Hungary,   Italy,   New Zealand,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01716585
Other Study ID Numbers  ICMJE M11-646
2012-002019-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nancy Shulman, MD AbbVie
PRS Account AbbVie
Verification Date October 2015

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