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

NCT ID: NCT03710252

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-09-30

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)

Group Type: EXPERIMENTAL

paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

Intervention Type: DRUG

OMB/PTV/r + DSV +/- RBV

Interventions

paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

OMB/PTV/r + DSV +/- RBV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

American Research Corporation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Poordad, MD

Role: PRINCIPAL_INVESTIGATOR

American Research Corporation

Other Identifiers

TLI_IIS_01_2015

Identifier Type: -

Identifier Source: org_study_id