Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

Hepatitis C Clinical Trial

Official title:
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects With Chronic HCV GT1 or GT3 Infection Who Have Failed a Direct Acting Antiviral Regimen

Status Terminated

Clinical Trial Summary

This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.

Clinical Trial Description

This trial was divided into Part A and Part B. In Part A, comprised of 4 treatment arms, C or NC participants with HCV genotype (GT) 1 infection previously failing a DAA regimen of either sofosbuvir (SOF)/ledipasvir (LDV) [Arms 1 and 2] or elbasvir (EBR)/GZR [Arms 3 and 4] were randomized to receive either one of the following: 1) MK-3682B + RBV for 16 weeks [Arms 1 and 3]; or 2) MK-3682B for 24 weeks [Arms 2 and 4]. Study Part A was completed as planned per study protocol. In Part B, C or NC participants with GT1 through GT6 infection previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT 3 only) were to receive MK-3682B for 16 weeks. However, the trial was terminated prior to participant enrollment for study Part B. Participants in MK-5172-017 (NCT01667081) were eligible for enrollment in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02613403
Study type	Interventional
Source	Merck Sharp & Dohme LLC
Contact
Status	Terminated
Phase	Phase 2
Start date	December 10, 2015
Completion date	March 27, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Recruiting	`NCT04510246` - Link Hepatitis C Notifications to Treatment in Tasmania	N/A
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03118674` - Harvoni Treatment Porphyria Cutanea Tarda	Phase 2
Completed	`NCT03109457` - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed	`NCT01458054` - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults	Phase 1
Completed	`NCT03740230` - 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
Completed	`NCT03426787` - Helping Empower Liver and Kidney Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Completed	`NCT00006301` - Immune Response to Hepatitis C Virus
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Completed	`NCT03365635` - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C	Phase 4
Recruiting	`NCT04405024` - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients	N/A
Completed	`NCT04525690` - Improving Inpatient Screening for Hepatitis C	N/A
Completed	`NCT04033887` - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn	`NCT04546802` - HepATocellular Cancer Hcv Therapy Study	Phase 3
Active, not recruiting	`NCT02961426` - Strategic Transformation of the Market of HCV Treatments	Phase 2/Phase 3
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Completed	`NCT02869776` - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing	N/A
Completed	`NCT02705534` - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.