You are about to leave an AbbVie Canada site, a Web site maintained by AbbVie Corporation.

This link is provided for your convenience only. AbbVie Corporation takes no responsibility for the content of any Web site maintained by any third party and makes no representation as to the accuracy or completeness of any information contained on this or any subsequent link.

Do you wish to leave this site?

Yes No

You are here

TURQUOISE-II

A Study to Evaluate the Safety and Effect of ABT-450, Ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

    Status Completed
    Related Conditions
    Chronic Hepatitis C

Enrollment Details

381 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Brief summary

Top

The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with ribavirin (RBV) in HCV genotype 1-infected adults with compensated cirrhosis.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 70 Years

Canada: 6

0
Calgary, AB
1
Edmonton, AB
2
Montreal, QC
3
Toronto, ON
4
Vancouver, BC
5
Vancouver, BC
Would you like to know more about this trial?

Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    Allocation

    Randomized

  • 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

    Parallel Assignment

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

    Masking

    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.
    ?

    Purpose

    Treatment

    • Male or female and age is between 18 and 70 years, inclusive, at time of Screening.
    • Chronic HCV-infection prior to study enrollment.
    • Screening laboratory result indicating HCV genotype 1-infection.
    • Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
    • Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
    • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
    • Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
    • Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
    • A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
    • Any cause of liver disease other than chronic HCV-infection, including but not limited to the following:
    • Hemochromatosis
    • Alpha-1 antitrypsin deficiency
    • Wilson's disease
    • Autoimmune hepatitis
    • Alcoholic liver disease
    • Drug-related liver disease

More on this trial

Clinical Trials.gov