An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs (Maviret PMS)
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|ClinicalTrials.gov Identifier: NCT03740230|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : April 29, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs"|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug ]SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after end of treatment.
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 30 weeks ]On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ persistently during treatment period.
- Percentage of Participants With Post-treatment Relapse [ Time Frame: Up to 28 weeks ]Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740230
|Contact: HyeYeon Kim||+82 2 3429 firstname.lastname@example.org|
|Contact: SoHee Kang||+82 2 3429 email@example.com|
|Study Director:||AbbVie Inc.||AbbVie|