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A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

    Status Completed
    Related Conditions
    Chronic Hepatitis C Infection
    Compensated Cirrhosis
    Hepatitis C Virus

Enrollment Details

60 Worldwide Enrollment Goal


  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID

Brief summary


A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 6

Calgary, AB
Ottawa, ON
Toronto, ON
Toronto, ON
Vancoucer, BC
Vancouver, BC
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Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.

    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.

    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.


    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.



    • Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
      • Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
      • HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
    • Screening laboratory result indicating HCV genotype 1b-infection.
    • Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.
    • Women who are pregnant or breastfeeding.
    • Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
    • Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
    • Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
    • Screening laboratory analyses showing any of the following abnormal laboratory results:
      • Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
      • Albumin < 2.8 g/dL
      • International normalized ratio (INR) > 1.8. Subjects with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
      • Hemoglobin < 10 g/dL
      • Platelets < 25,000 cells per mm3
      • Total bilirubin > 3.0 mg/dL

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