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

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

• Registration Number: NCT03710252
• Lead Sponsor: American Research Corporation

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.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Study First Submitted: 2018-09-25
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin	Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)	12 weeks after last treatment	Secondary Analysis