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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2016
Primary Completion Date
September 1, 2017
Completion Date
September 1, 2017
Last Updated
October 18, 2018
100
ACTUAL participants
paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin
DRUG
Lead Sponsor
American Research Corporation
Collaborators
NCT00199719
NCT06922643
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03612973