Hepatitis C Clinical Trial
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
|Source||Merck Sharp & Dohme Corp.|
|Start date||February 2013|
|Completion date||May 2015|
This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.
Part A is being done treatment-naïve (TN), genotype 1 (GT1), interferon eligible,
non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be
assigned randomly to 1 of 2 treatment arms in which they will receive grazoprevir 100 mg
once daily (QD) + elbasvir 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment
arm in which they will receive grazoprevir 100 mg QD + elbasvir 50 mg QD without RBV.
Treatment will last 12 weeks.
In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA) levels of ≥10,000 IU/mL will be randomly assigned to a study arm, based on absence or presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus (HIV); these participants will receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.
In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of ≥10,000 IU/mL will be randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) ± RBV. Treatment will last 8 weeks.
In Part D, TN N-C participants with HCV GT3 and HCV RNA levels of ≥10,000 IU/mL will be randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) + RBV for 12 or 18 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|Completed||NCT00006301 - Immune Response to Hepatitis C Virus||N/A|
|Not yet recruiting||NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma||N/A|
|Recruiting||NCT02683005 - Study of Hepatitis C Treatment During Pregnancy||Phase 1|
|Recruiting||NCT02961426 - Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection||Phase 2/Phase 3|
|Recruiting||NCT02781649 - Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients||Phase 1|
|Active, not recruiting||NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1||Phase 3|
|Completed||NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study||N/A|
|Not yet recruiting||NCT02869776 - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing||N/A|
|Recruiting||NCT02393365 - Prevalence and Screening of Hepatitis C in Belgium in 2015||N/A|
|Completed||NCT02487199 - Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease||Phase 3|
|Completed||NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics||Phase 3|
|Active, not recruiting||NCT01962441 - SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection||Phase 3|
|Active, not recruiting||NCT02103439 - An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients||Phase 3|
|Completed||NCT01830205 - Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment||Phase 1|
|Completed||NCT01682720 - Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection||Phase 3|
|Completed||NCT01441180 - GS-7977 With Ribavirin for Hepatitis C (SPARE)||Phase 1/Phase 2|
|Not yet recruiting||NCT01426204 - Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)||N/A|
|Completed||NCT01389323 - BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C||Phase 3|
|Completed||NCT01445795 - Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects||Phase 1/Phase 2|
|Completed||NCT01431898 - Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection||Phase 1|