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Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

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: NCT02207088
Recruitment Status : Completed
First Posted : August 1, 2014
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 1, 2014
Results First Submitted Date  ICMJE October 13, 2017
Results First Posted Date  ICMJE November 9, 2017
Last Update Posted Date November 9, 2017
Actual Study Start Date  ICMJE September 23, 2014
Actual Primary Completion Date December 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
Percentage of subjects with Sustained Virologic Response 12 weeks post-treatment [ Time Frame: 12 Weeks after the last actual dose of study drug ]
HCV RNA less than the lower limit of quantification.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 24 weeks ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
  • Percentage of Participants With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • Percentage of subjects with on-treatment virologic failure [ Time Frame: Up to 12 weeks ]
    The percentage of subjects with confirmed, quantifiable HCV RNA among subjects with previous unquantifiable HCV RNA during treatment.
  • Percentage of subjects with post-treatment relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]
    The percentage of subjects with confirmed, quantifiable HCV RNA between the end of treatment and 12 weeks after the last dose of study drug among subjects completing treatment and with unquantifiable HCV RNA at the end of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Official Title  ICMJE An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)
Brief Summary This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • Hepatitis C Virus
  • Compensated Cirrhosis
  • Severe Renal Impairment
  • End-stage Renal Disease
Intervention  ICMJE
  • Drug: ombitasvir/paritaprevir/ritonavir
    tablet
    Other Names:
    • ABT-450/r/ABT-267
    • Viekira Pak
    • paritaprevir also known as ABT-450
    • ombitasvir also known as ABT-267
    • dasabuvir also known as ABT-333
  • Drug: dasabuvir
    tablet
    Other Name: ABT-333
  • Drug: Ribavirin
    tablet
    Other Name: RBV
Study Arms  ICMJE Experimental: 3-DAA (Direct Acting Antivirals) with or without RBV
3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
Interventions:
  • Drug: ombitasvir/paritaprevir/ritonavir
  • Drug: dasabuvir
  • Drug: 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 13, 2017)
68
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2014)
40
Actual Study Completion Date  ICMJE December 6, 2016
Actual Primary Completion Date December 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.
  2. Screening laboratory result indicating HCV genotype 1 infection.
  3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
  4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
  3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 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 United States
 
Administrative Information
NCT Number  ICMJE NCT02207088
Other Study ID Numbers  ICMJE M14-226
2014-001527-77 ( EudraCT Number )
Has Data Monitoring Committee No
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: Eric Cohen, MD AbbVie
PRS Account AbbVie
Verification Date October 2017

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