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A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study (HEARTLAND)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin
Sponsored by
American Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years

    • Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b)
    • Patient and partner(s) must agree to use acceptable methods of contraception
    • Patient must be able to read and understand English and/or Spanish
    • Written informed consent

Exclusion Criteria:

  • Currently taking or planning on taking any prohibited medications (see US PI)

    • Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy

    • Abnormal lab values, including:

      • Hemoglobin (Hgb) <8 g/dL
      • Platelets <25,000 cells/mm3
      • Absolute neutrophil count (ANC)<500 cells/mm3
      • Bilirubin >3
      • INR>2.3 ALT/AST > 10 x ULN
      • Serum albumin <2.8
      • GFR <30 mL
    • Alcohol use: >3 drinks per day consistently
    • Uncontrolled HIV or HBV coinfection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single

    Arm Description

    Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)

    Outcomes

    Primary Outcome Measures

    The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
    Primary Analysis

    Secondary Outcome Measures

    Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)
    Secondary Analysis
    Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)
    Secondary Analysis. Comparison between baseline and end of treatment
    Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)
    Secondary Analysis

    Full Information

    First Posted
    September 25, 2018
    Last Updated
    October 17, 2018
    Sponsor
    American Research Corporation
    Collaborators
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03710252
    Brief Title
    A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study
    Acronym
    HEARTLAND
    Official Title
    A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    American Research Corporation
    Collaborators
    AbbVie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
    Detailed Description
    This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting. The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir. In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a Phase IV, open label, single arm study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Experimental
    Arm Description
    Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)
    Intervention Type
    Drug
    Intervention Name(s)
    paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin
    Intervention Description
    OMB/PTV/r + DSV +/- RBV
    Primary Outcome Measure Information:
    Title
    The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
    Description
    Primary Analysis
    Time Frame
    12 weeks after last treatment
    Secondary Outcome Measure Information:
    Title
    Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)
    Description
    Secondary Analysis
    Time Frame
    12 weeks after last treatment
    Title
    Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)
    Description
    Secondary Analysis. Comparison between baseline and end of treatment
    Time Frame
    12 weeks after last treatment
    Title
    Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)
    Description
    Secondary Analysis
    Time Frame
    12 weeks after last treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b) Patient and partner(s) must agree to use acceptable methods of contraception Patient must be able to read and understand English and/or Spanish Written informed consent Exclusion Criteria: Currently taking or planning on taking any prohibited medications (see US PI) Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy Abnormal lab values, including: Hemoglobin (Hgb) <8 g/dL Platelets <25,000 cells/mm3 Absolute neutrophil count (ANC)<500 cells/mm3 Bilirubin >3 INR>2.3 ALT/AST > 10 x ULN Serum albumin <2.8 GFR <30 mL Alcohol use: >3 drinks per day consistently Uncontrolled HIV or HBV coinfection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fred Poordad, MD
    Organizational Affiliation
    American Research Corporation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study

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