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Clinical Trial Details

Trial ID: L1569
Source ID: NCT02092350
Associated Drug: Grazoprevir
Title: Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Acronym: C-SURFER
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02092350/results
Conditions: Hepatitis C Virus
Interventions: DRUG: Grazoprevir|DRUG: Elbasvir|DRUG: Placebo to Grazoprevir|DRUG: Placebo to Elbasvir
Outcome Measures: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12), SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL., Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)|Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods, An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group., Up to Week 14|Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period, An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group., Up to Week 12 | Secondary: Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24), SVR24 was defined as HCV RNA \<LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL., Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)|Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4), SVR4 was defined as HCV RNA \<LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL., Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 237
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-03-17
Completion Date: 2015-09-02
Results First Posted: 2016-04-12
Last Update Posted: 2018-09-24
Locations:
URL: https://clinicaltrials.gov/show/NCT02092350