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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT02442284
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 30, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 13, 2015
Results First Submitted Date  ICMJE July 31, 2017
Results First Posted Date  ICMJE August 30, 2017
Last Update Posted Date October 16, 2017
Actual Study Start Date  ICMJE May 13, 2015
Actual Primary Completion Date August 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ 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. Participants with missing data after backwards imputation were imputed as nonresponders.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
Percentage of participants with Sustained Virologic Response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) less than the lower limit of quantification
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders [ 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. Participants with missing data after backwards imputation were imputed as nonresponders.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Up to 24 weeks while on treatment ]
    The percentage of participants with confirmed, quantifiable HCV RNA levels among participants with previous unquantifiable HCV RNA during treatment and participants who did not achieve unquantifiable HCV RNA at end of treatment.
  • Percentage of participants with virologic relapse post-treatment [ Time Frame: Up to 24 weeks after last actual dose of study drug ]
    The percentage of participants with confirmed, quantifiable HCV RNA levels among participants with previous unquantifiable HCV RNA at the end of treatment
  • Percentage of participants with Sustained Virologic Response 12 weeks post-treatment among participants with ongoing psychiatric disorders [ Time Frame: 12 weeks after the last actual dose of study drug ]
    Hepatitis C virus (HCV) ribonucleic acid (RNA) levels less 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 the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Official Title  ICMJE An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
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
  • Cirrhosis
  • Hepatitis C Virus
Intervention  ICMJE
  • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
    Other Names:
    • Viekira Pak
    • paritaprevir also known as ABT-450
    • ombitasvir also known as ABT-267
    • dasabuvir also known as ABT-333
  • Drug: Ribavirin
    Tablet
Study Arms  ICMJE Experimental: 3-DAA ± RBV for 12 or 24 weeks
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Interventions:
  • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
  • Drug: Ribavirin
Publications * Not Provided

*   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: November 1, 2016)
99
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
100
Actual Study Completion Date  ICMJE October 31, 2016
Actual Primary Completion Date August 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • US military veteran currently receiving healthcare through the Veterans Health Administration
  • Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
  • Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
  • Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
  • Any current or past clinical evidence of Child-Pugh B or C classification
  • Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT02442284
Other Study ID Numbers  ICMJE M14-251
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: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2017

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