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A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

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ClinicalTrials.gov Identifier: NCT01221298
Recruitment Status : Completed
First Posted : October 15, 2010
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE October 15, 2010
Results First Submitted Date  ICMJE December 29, 2014
Results First Posted Date  ICMJE January 8, 2015
Last Update Posted Date January 8, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [ Time Frame: Week 4 through Week 12 ]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
Percentage of subjects with Hepatitis C Virus Ribonucleic acid suppressed below the lower limit of quantitation [ Time Frame: For a duration of 8 weeks, beginning at Study Week 4 and ending after the completion of Study Week 12 ]
Analysis of the percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of quantitation from Study Week 4 through the completion of Study Week 12
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) [ Time Frame: Week 2 ]
    Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
  • Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 [ Time Frame: Week 4 ]
    Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
  • Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment [ Time Frame: Post-treatment Day 1 to Post-treatment Week 12 ]
    Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
  • Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment [ Time Frame: Post-treatment Day 1 to Post-treatment Week 24 ]
    Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.
  • Time to Failure to Suppress or Rebound During Treatment [ Time Frame: Day 1 through Week 12 ]
    The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.
  • Time to Virologic Relapse Through 24 Weeks Post-treatment [ Time Frame: Post-treatment Day 1 to Post-treatment Week 24 ]
    Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
  • Percentage of subjects with HCV RNA less than lower limit of quantitation [ Time Frame: At Study Week 4 ]
    Analysis of percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of quantitation at Study Week 4
  • The time to relapse after the treatment regimen [ Time Frame: For a duration of 48 weeks beginning after the completion of Study Week 12 and ending after the completion of Post-Study Week 48 ]
    Analysis of the time to a confirmed Hepatitis C Virus Ribonucleic acid greater than the lower limit of detection
  • Percentage of subjects with Sustained Viral Response(12) or Sustained Viral Response(24) [ Time Frame: Post-Study Week 12 and Post-Study Week 24 ]
    Analysis of the percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of detection 12 weeks post Direct Acting Antiviral Agent therapy, or Hepatitis C Virus Ribonucleic acid less than the lower limit of detection 24 weeks post Direct Acting Antiviral Agent therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Official Title  ICMJE An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Brief Summary The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Detailed Description This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • HCV
  • Chronic Hepatitis C Infection
  • Hepatitis C Genotype 1
Intervention  ICMJE
  • Drug: ABT-450
    tablets
  • Drug: ABT-072
    tablets
  • Drug: Ribavirin
    tablets
  • Drug: Ritonavir
    capsules
    Other Name: Norvir
Study Arms  ICMJE Experimental: ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Interventions:
  • Drug: ABT-450
  • Drug: ABT-072
  • Drug: Ribavirin
  • Drug: Ritonavir
Publications * Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.

*   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: April 16, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2010)
20
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
  • Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
  • Treatment naïve male or female between the ages of 18 and 65.
  • Females must be postmenopausal for at least 2 years or surgically sterile.
  • Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
  • Body mass index 18 to < 35 kg/m^2 .

Exclusion Criteria:

  • Significant sensitivity to any drug.
  • Use of herbal supplements within 2 weeks prior to study drug dosing.
  • Positive screen for certain drugs or alcohol.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
  • Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
  • Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
  • Abnormal laboratory tests.
  • Cirrhosis or extensive bridging fibrosis.
  • History of cardiac disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221298
Other Study ID Numbers  ICMJE M12-267
Has Data Monitoring Committee No
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: Daniel Cohen, MD AbbVie
PRS Account AbbVie
Verification Date December 2014

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