NCT03710252

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: American Research Corporation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin	OMB/PTV/r + DSV +/- RBV

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2018-10-18
• Last updated: 2018-10-18