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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. 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).
  2. Screening laboratory result indicating HCV genotype 1b-infection.
  3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
  3. 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.
  4. 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.)
  5. Use of contraindicated medications within 2 weeks of dosing
  6. 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. Participants 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20129608

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