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Trial record 1 of 4 for:    hcv pragmatic
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Study of Oral Treatments for Hepatitis C (PRIORITIZE)

This study is currently recruiting participants.
Verified August 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT02786537
First Posted: June 1, 2016
Last Update Posted: August 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Patient-Centered Outcomes Research Institute
Merck Sharp & Dohme Corp.
AbbVie
Information provided by (Responsible Party):
University of Florida
  Purpose
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 Intervention Phase
Chronic Hepatitis C Drug: sofosbuvir/ledipasvir Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only) Drug: elbasvir/grazoprevir Drug: Dasabuvir Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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:
  • 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)


Estimated Enrollment: 2670
Study Start Date: June 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Briana Foerman, BS 352-294-5152 briana.foerman@medicine.ufl.edu
Contact: Lauren E Morelli, BA 352-273-9508 lauren.morelli@medicine.ufl.edu

  Show 38 Study Locations
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Merck Sharp & Dohme Corp.
AbbVie
Investigators
Principal Investigator: David R Nelson, MD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02786537     History of Changes
Other Study ID Numbers: 16-1234
First Submitted: May 17, 2016
First Posted: June 1, 2016
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Sofosbuvir
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