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 : May 16, 2019
|Condition or disease|
Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label.
The sample size for this study is due to a requirement by local authorities.
|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 :||October 15, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740230
|Contact: Haney Choi||+82 2 3429 email@example.com|
|Contact: EunJung Gu||+82 2 3429 firstname.lastname@example.org|
Show 51 Study Locations
|Study Director:||AbbVie Inc.||AbbVie|