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

American Research Corporation

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03710252

TLI_IIS_01_2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Single

Experimental group

Description:

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

Treatment:

Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin