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A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection (PEARL-IV)

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: NCT01833533
Recruitment Status : Completed
First Posted : April 17, 2013
Results First Posted : January 6, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 27, 2013
First Posted Date  ICMJE April 17, 2013
Results First Submitted Date  ICMJE December 23, 2014
Results First Posted Date  ICMJE January 6, 2015
Last Update Posted Date September 21, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 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; Primary Analyses [ Time Frame: 12 weeks after last dose of 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. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2013)
Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the 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 Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment [ Time Frame: Baseline (Day 1) and Week 12 (End of Treatment) ]
    The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses [ Time Frame: 12 weeks after last dose of study drug ]
    The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12 ]
    Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
  • Percentage of Participants With Virologic Relapse After Treatment [ Time Frame: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment) ]
    Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2013)
  • Changes in hemoglobin laboratory values during treatment [ Time Frame: Day 1 through Week 12 ]
    Hemoglobin laboratory values below the the lower limit of normal
  • Percentage of subjects with virologic failure during treatment [ Time Frame: Up to Week 12 ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification
  • Percentage of subjects with virologic relapse after treatment [ Time Frame: Up to post-treatment Week 48 ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification
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 in Adults With Genotype 1a Infection
Official Title  ICMJE A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)
Brief Summary The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.
Detailed Description A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.
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
    Tablet; 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
  • Drug: Placebo for Ribavirin
    Capsule
Study Arms  ICMJE
  • Experimental: ABT-450/r/ABT-267 and ABT-333, Plus RBV
    ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based 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: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Interventions:
    • Drug: ABT-450/r/ABT-267, 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: September 16, 2014)
305
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2013)
300
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
  • Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
  • Subject has never received antiviral treatment for hepatitis C infection
  • 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 or anti-human immunodeficiency virus antibody
  • Positive screen for drugs or alcohol
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests
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 Canada,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01833533
Other Study ID Numbers  ICMJE M14-002
2012-005522-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yan Luo, MD AbbVie
PRS Account AbbVie
Verification Date September 2015

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