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

Study Identifier
P20-397
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    South Ural State Medical University /ID# 226555
    Chelyabinsk, Russian Federation, 454048
    Status
    Not applicable
    Location
    LLC Center of Targeted Therapy /ID# 239529
    Domodedovo, Russian Federation, 142007
    Status
    Not applicable
    Location
    Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
    Irkutsk, Russian Federation, 664035
    Status
    Not applicable
    Location
    Specialized Clinical Infectious Diseases Hospital /ID# 229814
    Krasnodar, Russian Federation, 350000
    Status
    Not applicable
    Location
    Infectious Clinical Hosp #1 /ID# 225063
    Moscow, Russian Federation, 125310
    Status
    Not applicable
    Location
    Infectious Clinical Hospita l#2 /ID# 243217
    Nizhny Novgorod, Russian Federation, 603022
    Status
    Not applicable
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