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

Chronic Hepatitis C Clinical Trial

— HEARTLAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710252
• Other study ID #: TLI_IIS_01_2015
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2018
• Source: American Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
American Research Corporation	AbbVie

Outcome

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