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AGATE-1

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

    Status Active, not recruiting
    Related Conditions

Enrollment Details

190 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M11-665

Brief summary

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The purpose of this study in HCV genotype 4-infected subjects with compensated cirrhosis is to assess the safety and to compare the percentage of subjects achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold [based on SVR rates for HCV genotype 4-infected subjects treated with pegylated interferon (pegIFN)/RBV].

The 12 and 16-week arms have been fully enrolled. As of 19 May 2015, they were closed and the two 24-week arms were opened for enrollment.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 2

0
Toronto, ON
1
Vancouver, BC
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Study Design

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

    Parallel Assignment

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

    Treatment

  • Subjects must meet one of the following:

    Treatment-naive (Subject has never received antiviral treatment for hepatitis C infection) OR For Arms A, B, and C:

    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV)

    For Arm D:

    • Treatment Experienced (Prior sofosbuvir (SOF) breakthrough/non-responder or Prior SOF relapser to SOF/pegIFN/RBV or SOF/RBV)
    • Subject has plasma HCV RNA > 1000 IU/mL at Screening
    • Chronic HCV genotype 4 infection with cirrhosis
    • Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
    • Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational or commercially available (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. Prior use of any direct-acting antiviral will not be allowed, except for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegIFN/RBV or SOF with RBV is required.
    • Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy.
    • Confirmed presence of hepatocellular carcinoma.
    • Any cause of liver disease other than chronic HCV infection.
    • Abnormal laboratory tests.

More on this trial

Clinical Trials.gov