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Trial record 31 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Zepatier in Patients With Substance Use

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ClinicalTrials.gov Identifier: NCT04048850
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sarah Michienzi, University of Illinois at Chicago

Tracking Information
First Submitted Date August 1, 2019
First Posted Date August 7, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date September 20, 2019
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2019)
SVR - PP [ Time Frame: 12 weeks after the end of therapy (SVR-12) ]
Proportion of patients in the per-protocol (PP) population with sustained virologic response (SVR). PP: excludes non-treatment related discontinuations and patients lost to follow-up before SVR-12 laboratory test.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04048850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 5, 2019)
  • SVR - stratified [ Time Frame: 12 weeks after the end of therapy (SVR-12) ]
    PP SVR-12 stratified by pre-specified baseline characteristics:
    • HCV monoinfection
    • HIV-HCV co-infection
    • Cirrhosis
    • Positive baseline urine toxicology
    • Men who have sex with men (MSM)
    • Commercial sex work
    • Diagnosed concomitant psychiatric disorder(s)
    • Use of concomitant medication(s)
    • Specific substance(s) used
  • Drug-Drug interactions (DDIs) [ Time Frame: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks ]
    Interventions to prevent or remedy known or suspected DDIs between elbasvir/grazoprevir and concomitant prescription or over-the-counter medications, supplements, and substance of use
  • Adherence [ Time Frame: During 12 weeks of treatment ]
    Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses
  • SVR - ITT [ Time Frame: 12 weeks after the end of therapy (SVR-12) ]
    Proportion of patients in the intention-to-treat (ITT) population with SVR-12. ITT: all patients who received at least one dose of Zepatier (elbasvir/grazoprevir)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Zepatier in Patients With Substance Use
Official Title Cohort Study of Hepatitis C Virus Treatment With Zepatier (Elbasvir/Grazoprevir) in Genotype 1 or 4 HCV Treatment-Naïve or Peginterferon/Ribavirin-Experienced Patients With Substance Use in Urban, Multidisciplinary Specialty Clinics
Brief Summary The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.
Detailed Description Previously, people who use substances and those without liver fibrosis or cirrhosis were excluded from receiving direct-acting antiviral (DAA) treatment due to Illinois Medicaid restrictions. These sobriety and staging restrictions were recently lifted. However, due to these previous stringent requirements for sobriety, many patients were not able to be treated for HCV. This created a data gap for real-world outcomes of HCV treatment in people who use substances. This study presents a unique opportunity to provide patients with hepatitis C treatment and obtain much needed data on the use of elbasvir/grazoprevir in patients with substance use and other underrepresented comorbidities. Additionally, this study will determine if our current standard of care for the treatment of HCV is effective for patients with substance use.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The specific patient population to be studied is HCV monoinfected and HIV-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients of the UI Health Infectious Disease or Liver Clinic with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use treated with 12 weeks of elbasvir/grazoprevir therapy.
Condition
  • Hepatitis C
  • Hiv
  • Coinfection, HIV
  • Substance Use Disorders
Intervention Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
Daily medication
Other Name: Zepatier
Study Groups/Cohorts Patients living with HCV +/- HIV
HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use treated with elbasvir/grazoprevir 50-100 mg fixed-dose-combination, 1 tablet by mouth daily, for 12 weeks.
Intervention: Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
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 Enrolling by invitation
Estimated Enrollment
 (submitted: August 5, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2021
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults (at least 18 years of age or older)
  • Chronic HCV (HCV antibody positive with detectable HCV-RNA)
  • HCV genotypes 1a, without the presence of baseline NS5A resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4
  • HCV treatment-naïve or peginterferon/ribavirin-experienced
  • Managed by the UI Health Infectious Diseases Clinic or Liver Clinic
  • Recent or current substance use (per self-report or electronic medical record (EMR) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: Opiate substitution therapy; Prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); Illicit substances; Injection drug use; Alcohol

Exclusion Criteria:

  • Incarcerated
  • Pregnant or breastfeeding
  • Decompensated liver disease (Child-Pugh B or C)
  • Albumin below 3 g/dL
  • Platelet count below 75,000
  • Unwilling to commit to treatment and/or monitoring
  • Poor venous access inhibiting laboratory collection
  • Any condition considered by the investigators to be a contraindication to study participation
  • Hepatitis B virus (HBV) surface antigen (HBsAg) positive
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04048850
Other Study ID Numbers 2019-0478
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
Plan to Share IPD: No
Responsible Party Sarah Michienzi, University of Illinois at Chicago
Study Sponsor University of Illinois at Chicago
Collaborators Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sarah Michienzi, PharmD University of Illinois at Chicago College of Pharmacy
PRS Account University of Illinois at Chicago
Verification Date September 2019