Grazoprevir + Elbasvir
DrugFDC tablet containing grazoprevir 100 mg and elbasvir 50 mg.
Other names: MK-5172A
NCT Number: NCT02105701
This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDC tablet containing grazoprevir 100 mg and elbasvir 50 mg.
Other names: MK-5172A
200 mg capsule
Other names: Rebetol®
Time frame: 12 weeks after the end of all study treatment (up to 28 weeks)
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Time frame: Up to 18 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 16 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: 24 weeks after the end of all study treatment (up to 40 weeks)
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Merck Sharp & Dohme LLC
Industry
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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