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

ClinicalTrial.gov Identifier : NCT01464827

A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects

    Status Completed
    Related Conditions
    Chronic Hepatitis C

Enrollment Details

560 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Brief summary

Top

This is a study of combination direct-acting antiviral agents (DAA) and/or Ribavirin (RBV) in subjects with chronic Hepatitis C Virus (HCV).

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

Canada: 2

0
Calgary, AB
1
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

    • Males and females 18-70 years old, inclusive
    • Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
    • Chronic Hepatitis C Virus (HCV), genotype 1 infection
    • Treatment naive OR prior null-responders to previous treatment with pegylated interferon (pegIFN) and Ribavirin (RBV)
    • No evidence of liver cirrhosis
    • Positive screen for drugs and alcohol
    • Significant sensitivity to any drug
    • Use of contraindicated or prohibited medications within 1 month of dosing
    • Abnormal laboratory tests

More on this trial

Clinical Trials.gov