CompletedNot Applicable

Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Austria2,118 participantsStarted 2017-11-13

Plain-language summary

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials. This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

Who can participate

SexALL

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Inclusion Criteria: * Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen 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 * Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial. Exclusion Criteria: None.

What they're measuring

Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)

Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir

Trial details

NCT IDNCT03303599

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-24

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