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Study of Oral Treatments for Hepatitis C (PRIORITIZE)

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: 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

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: sofosbuvir/ledipasvir Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only) Drug: elbasvir/grazoprevir Drug: Dasabuvir Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders
Study Start Date : June 2016
Actual Primary Completion Date : June 13, 2019
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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)

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)
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: Dasabuvir
250 mg daily for 12 to 24 weeks
Other Name: Viekira Pak

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)
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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of patients who report missing pills (doses) (Voils' Medication Adherence Survey) [ Time Frame: 12-16 weeks of HCV treatment ]
    Treatment Adherence

  2. 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

  3. 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

  4. 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.

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786537


  Hide Study Locations
Locations
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United States, Arkansas
Liver Wellness Center
Little Rock, Arkansas, United States, 72205
United States, California
Stanford University
Palo Alto, California, United States, 94304
UCSD Medical Center
San Diego, California, United States, 92103
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
Univ of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale University Digestive Diseases
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Howard University
Washington, District of Columbia, United States, 20060
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0272
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Georgia
Internal Medicine Associates of Wellstar Atlanta Medical Center
Atlanta, Georgia, United States, 30312
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60647
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
John Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GI Associates & Endoscopy Center
Flowood, Mississippi, United States, 39232
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, Nebraska
University of Nebraska Medical Ctr
Omaha, Nebraska, United States, 68198
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Mt. Sinai Beth Israel
New York, New York, United States, 10003
New York Langone Medical Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
Mountain View Medical Center
Valatie, New York, United States, 12184
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
United States, Virginia
Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
Richmond, Virginia, United States, 23226
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Merck Sharp & Dohme Corp.
AbbVie
Investigators
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Principal Investigator: David R Nelson, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02786537     History of Changes
Other Study ID Numbers: 16-1234
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by University of Florida:
Hepatitis C

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Sofosbuvir
MK-5172
Ledipasvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors