Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

Study Identifier
P20-276
CT.gov Identifier
NCT04352309
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+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label. * Participants may be enrolled up to 4 weeks after treatment initiation.
    Exclusion Criteria:
    * Participating or intending to participate in a concurrent interventional therapeutic trial.

    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) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.

    GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.

    Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.

    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# 225501
    Chelyabinsk, Russian Federation, 454052
    Status
    Not applicable
    Location
    Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499
    Irkutsk, Russian Federation, 664035
    Status
    Not applicable
    Location
    S. P. Botkin City Hospital /ID# 225500
    Oryol, Russian Federation, 302038
    Status
    Not applicable
    Location
    Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582
    Samara, Russian Federation, 443029
    Status
    Not applicable
    Location
    Stavropol State Medical University /ID# 226589
    Stavropol, Russian Federation, 355017
    Status
    Not applicable
    Location
    Medical center Academy /ID# 226587
    Ulyanovsk, Russian Federation, 432063
    Status
    Not applicable