A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

Study Identifier
P20-105
CT.gov Identifier
NCT04189627
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis * Treatment naive or treatment experienced participants * Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label * Participant and his/her legal representative voluntarily signs and dates an informed consent form * Must not be participating or intending to participant in a concurrent interventional therapeutic trial
    Exclusion Criteria:
    None

    Protocol Summary

    The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to \<18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir \[PRS\]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

    Study Locations

    Location
    Status
    Location
    Dagestan State Medical University /ID# 218500
    Makhachkala, Dagestan, Respublika, Russian Federation, 367000
    Status
    Not applicable
    Location
    A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498
    Kazan', Tatarstan, Respublika, Russian Federation, 420140
    Status
    Not applicable
    Location
    South-Ural Medical State University /ID# 218501
    Chelyabinsk, Russian Federation, 454048
    Status
    Not applicable
    Location
    Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252
    Irkutsk, Russian Federation, 664035
    Status
    Not applicable
    Location
    Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590
    Moscow, Russian Federation, 115093
    Status
    Not applicable
    Location
    Infectious Clinical Hosp #1 /ID# 218497
    Moscow, Russian Federation, 125310
    Status
    Not applicable
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