Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV
NCT03037151 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-02-13
Summary
This study will evaluate the safety and efficacy of combination treatment with grazoprevir + elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6 (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV) infection.
Conditions
- Compensated Cirrhosis
Interventions
- DRUG
-
Grazaoprevir/Elbasavir
treatment naive
- DRUG
-
Grazaoprevir/Elbasavir/RBV
treatment experienced
Sponsors & Collaborators
-
Chulalongkorn University
collaborator OTHER - collaborator INDUSTRY
-
The HIV Netherlands Australia Thailand Research Collaboration
lead OTHER
Principal Investigators
-
Anchalee Avihingsanon, MD, PhD · HIV-NAT, Thai Red Cross - AIDS Research Centre
-
Pisit Tangkijvanich, MD · Chulalongkorn University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Thailand
Study Locations
More Related Trials
-
Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
NCT02092350 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
NCT02203149 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)
NCT02105701 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)
NCT02105688 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060)
NCT02105467 ·Status: COMPLETED ·Phase: PHASE3
-
Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)
NCT02204475 ·Status: WITHDRAWN ·Phase: PHASE3
-
Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
NCT03143998 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)
NCT02358044 ·Status: COMPLETED ·Phase: PHASE3
-
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
NCT02251990 ·Status: COMPLETED ·Phase: PHASE3
-
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)
NCT02105454 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)
NCT02332707 ·Status: COMPLETED ·Phase: PHASE2
-
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
NCT02890719 ·Status: WITHDRAWN ·Phase: PHASE3
-
Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4
NCT02886624 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection
NCT03098121 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)
NCT03111108 ·Status: COMPLETED ·Phase: PHASE4
-
Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
NCT03222167 ·Status: UNKNOWN ·Phase: PHASE3
-
Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation
NCT03723824 ·Status: TERMINATED ·Phase: PHASE4
-
Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease
NCT03145623 ·Status: COMPLETED
-
Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)
NCT02332720 ·Status: COMPLETED ·Phase: PHASE2
-
Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4
NCT03578640 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)
NCT02133131 ·Status: COMPLETED ·Phase: PHASE2
-
Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)
NCT02601573 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C
NCT03022006 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
NCT01717326 ·Status: COMPLETED ·Phase: PHASE2
-
Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)
NCT01353911 ·Status: COMPLETED ·Phase: PHASE2