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ClinicalTrials.gov Identifier: NCT02582632

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

    Status Recruiting
    Related Conditions
    Hepatitis C Infection
    Hepatitis C Virus

Enrollment Details

166 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M15-684

Brief summary

Top

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 100 Years

Canada: 3

0
Toronto, ON
1
Vancouver, BC
2
Winnipeg, MB
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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.
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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

    Single Group 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

    1. Chronic HCV infection at Screening.
    2. Screening laboratory result indicating HCV genotype 1b infection.
    3. Treatment-naïve and non-cirrhotic.
    1. HCV genotype or subtype other than GT1b.
    2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test).
    3. Any current or past clinical evidence of cirrhosis.
    4. Screening laboratory analyses that shows abnormal results.
    5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

More on this trial

Clinical Trials.gov