Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)
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|ClinicalTrials.gov Identifier: NCT02105454|
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 4, 2016
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus||Drug: Grazoprevir (GZR) Drug: Elbasvir (EBR) Drug: Ribavirin (RBV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 + MK-8742 + Ribavirin (R) in Subjects With Chronic Hepatitis C Virus Infection Who Failed Prior Direct Acting Antiviral Therapy|
|Actual Study Start Date :||May 23, 2014|
|Actual Primary Completion Date :||May 4, 2015|
|Actual Study Completion Date :||May 4, 2015|
Experimental: GZR 100 mg + EBR 50 mg + RBV for 12 weeks
Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Drug: Grazoprevir (GZR)
100 mg oral tablet (total daily dose)
Drug: Elbasvir (EBR)
10 mg oral capsule (total daily dose = 5 capsules)
Drug: Ribavirin (RBV)
200 mg oral capsule (total daily dose = 4-7 capsules)
- Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12) [ Time Frame: Up to 24 weeks ]SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.
- Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug) ]Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
- Percentage of Participants Discontinuing Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
- Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy [ Time Frame: Up to 24 weeks ]SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.
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): NCT02105454
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|