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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single; Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)	Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin; OMB/PTV/r + DSV +/- RBV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)	Secondary Analysis	12 weeks after last treatment
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	12 weeks after last treatment
Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)	Secondary Analysis	12 weeks after last treatment

Collaborators and Investigators

• Sponsor: American Research Corporation
• Collaborators: AbbVie
• Investigators: Principal Investigator: Fred Poordad, MD, American Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ribavirin; Ritonavir
• Other Study ID Numbers: TLI_IIS_01_2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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