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Study of Oral Treatments for Hepatitis C (PRIORITIZE)

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ClinicalTrials.gov Identifier: NCT02786537
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : July 4, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Merck Sharp & Dohme Corp.
AbbVie
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date July 4, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Percentage of Patients who Achieve Undetectable Hepatitis C Virus (HCV) RNA 12 Weeks after completing HCV treatment [ Time Frame: Post Treatment Week 12 ]
SVR12 will be defined as hepatitis C virus (HCV) RNA undetectable at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02786537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Number of patients who report missing pills (doses) (Voils' Medication Adherence Survey) [ Time Frame: 12-16 weeks of HCV treatment ]
    Treatment Adherence
  • Number of patients with reduction in fibrosis 3 years (Liver Biopsy/Fibroscan) post treatment baseline [ Time Frame: 3 years post treatment discontinuation ]
    Number of patients with reduction in Liver Biopsy Scores/Fibroscan Scores will be assessed by comparing baseline and post-treatment liver biopsy/fibroscan scores
  • Percentage of patients who are HCV RNA undetectable (cured) 3 years post-treatment [ Time Frame: 3 years after treatment discontinuation ]
    Percentage of patients who are still undetectable (HCV RNA) 3 years post-treatment
  • Number of patients with decrease in HCV-associated symptoms (PROMIS measures) after HCV treatment initiation [ Time Frame: 1 and 3 years post treatment discontinuation ]
    6 PROMIS scores recorded at baseline and at 1 and 3 years after treatment will be used to evaluate change from baseline.
  • Percentage of patients who have an increase in functional status (as reported on HCV-PRO questionnaire) [ Time Frame: Baseline, 1 year, and 2 years after treatment discontinuation ]
    Percentage of patients who have an increase in functional status (as reported on patient reported outcomes)
  • Number of participants with adverse events that caused treatment discontinuation [ Time Frame: Treatment start date through treatment completion (up to 24 weeks) ]
    The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oral Treatments for Hepatitis C
Official Title  ICMJE THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders
Brief Summary Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
Detailed Description

In Phase 1 of this study, consented subjects will be randomized to 1 of the following 3 HCV treatments:

1) Harvoni® 2)Viekira Pak™ 3)Zepatier™ (The addition of Ribavirin and the length of treatment will be determined by the provider). In Phase 2 of this study, consented subjects will be randomized to 1 of 2 FDA approved HCV treatments: 1)1) Harvoni® or 3)Zepatier™. Both Phase 1 and Phase 2 subjects will have up to 1 tablespoon of blood drawn for HCV resistance testing and future biorepository testing (if subject provides additional consent). The results of testing will determine whether a genotype 1a subject will be provided 12 or 16 wks of Zepatier (if randomized to Zepatier).

Following randomization, subjects will complete patient reported outcome questionnaires via electronic device or telephone. Following randomization, subjects will be asked to complete surveys again at Wk 4 of treatment, End of Treatment, 1 and 3 year post treatment. Subjects standard medical care will continue. Test results and medical records throughout treatment and for up to 3 years post treatment will be collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: sofosbuvir/ledipasvir
    Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)
    Other Name: Harvoni® (sofosbuvir/ledipasvir)
  • Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
    (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)
    Other Name: Viekira Pak (fixed dose combination of ombitasvir/paritaprevir/ritonavir) (Phase 1 only)
  • Drug: elbasvir/grazoprevir
    Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks with or without RBV
    Other Name: Zepatier (elbasvir/grazoprevir)
  • Drug: Dasabuvir
    250 mg daily for 12 to 24 weeks
    Other Name: Viekira Pak
Study Arms  ICMJE
  • Active Comparator: sofosbuvir/ledipasvir
    Subjects will take 1 tablet sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks with or without ribavirin (RBV) (per discretion of provider)
    Intervention: Drug: sofosbuvir/ledipasvir
  • Active Comparator: ombitasvir/paritaprevir/ritonavir & dasabuvir (Phase 1 only)
    Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks +/- RBV (provider discretion)
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
    • Drug: Dasabuvir
  • Active Comparator: elbasvir/grazoprevir tablet
    Subjects will take elbasvir/grazoprevir tablet tablet once daily with or without RBV for 12 to 16 weeks (provider discretion)
    Intervention: Drug: elbasvir/grazoprevir
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 13, 2018)
1676
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
3750
Estimated Study Completion Date  ICMJE February 2022
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HCV Genotype 1a or 1b
  • Adult patients (age 18 years or older)
  • Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni, Viekira Pak (Phase 1 only), or Zepatier)

Exclusion Criteria:

  • Inability to provide written informed consent
  • HARVONI® is not a covered drug on benefits formulary
  • Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)
  • Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)
  • Pregnant or breastfeeding women
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786537
Other Study ID Numbers  ICMJE 16-1234
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • Merck Sharp & Dohme Corp.
  • AbbVie
Investigators  ICMJE
Principal Investigator: David R Nelson, MD University of Florida
PRS Account University of Florida
Verification Date July 2019

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