Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response

  • STATUS
    Recruiting
  • End date
    Dec 14, 2021
  • participants needed
    67
  • sponsor
    AbbVie
Updated on 26 January 2021

Summary

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.

GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.

Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Details
Condition Hepatitis C, Hepatitis C virus
Clinical Study IdentifierNCT04577482
SponsorAbbVie
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have Hepatitis C virus?
Do you have any of these conditions: Hepatitis C or Hepatitis C virus?
Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label
Participants can enroll up to 4 weeks after starting treatment

Exclusion Criteria

Participating or intending to participate in a concurrent interventional therapeutic trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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