Clinical trial NCT03710252: A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study
Official title: A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Lead sponsor: American Research Corporation
Sponsor class: NETWORK
Collaborators: name: AbbVie
First posted: 2018-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a Phase IV, open label, single arm study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
timeFrame: 12 weeks after last treatment
Secondary outcomes:
measure: Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)
timeFrame: 12 weeks after last treatment
measure: Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)
timeFrame: 12 weeks after last treatment
measure: Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)
timeFrame: 12 weeks after last treatment
Other outcomes:
Locations:
Study officials:
affiliation: American Research Corporation
name: Fred Poordad, MD
role: PRINCIPAL_INVESTIGATOR
References: