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

NCT03710252 — Phase 4, Completed, 100 participants, American Research Corporation

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A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study

Registry	NCT03710252, acronym HEARTLAND
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	American Research Corporation (Network); collaborators: AbbVie
Conditions	Chronic Hepatitis C
Interventions	paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin (Drug)
Dates	start 2016-03-01, primary completion 2017-09-01, completion 2017-09-01, first posted 2018-10-18, last updated 2018-10-18

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Single	Experimental	Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin	Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)

paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin (Drug): OMB/PTV/r + DSV +/- RBV

+Outcome measures

Primary outcomes

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

Secondary outcomes

Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs) [12 weeks after last treatment]: Secondary Analysis
Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not) [12 weeks after last treatment]: Secondary Analysis. Comparison between baseline and end of treatment
Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not) [12 weeks after last treatment]: Secondary Analysis

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators

Fred Poordad, MD, Principal investigator, American Research Corporation